The context and background of the South African Cape Supreme Court judgement  of 13 May 2008 against the  Dr Matthias Rath Foundation (see the BBC article) and the South African ANC Government Ministry of Health , to stop illegal trials of vitamins in AIDS patients, is already concisely summed up in the updated Wikipedia Rath report of the same date, and the TAC report, and the self-damaging hard sell by the Rath Foundation itself.


To what extent the Rath group was conducting research trials as opposed to simply collecting feedback in a structured format becomes irrelevant when Rath websites and supporters manifestly urged patients not to take antimicrobials. It is epidemiogical bedrock that the inital study that leads to an hypothesis, and thus application for trials, permission and funding, is always observational – collation  and validation of data in the field. Provided confidentiality is maintained, and no intervention has been designed, no-one needs  ethical permission to collate and report data ethically collected from, for example, consumers or patients.  See this report by the National Ethics Advisory Committee (New Zealand) which proposes that ethical permission  is essential only for research purposes, but  is not necessary for observational study for audit or public health purpose.


What these reports do not clarify is the human background:


I saw just such a patient just before that judgement was given – a gaunt young middle-aged  Bantu factory owner whose wife has just had another baby, although the couple has recently become HIV positive.

Last year (when he was still HIV negative but lymphopaenic), his non-specific Reiter’s-type arthralgia after antibiotics settled on supplements; but since he stopped taking micronutrient supplements a month ago (already knowing he was HIV positive), he has develloped mouth sores, related cervical/ axillary adenopathy and now progressive dry cough and haemoptysis. Clinically he was still well, with chest clear clinically. This in a  family in townships where highly resistant TB has mushroomed. He came back for more supplements. He and his wife were firmly instructed to go for urgent TB screening, CD4 count, viral load and  appropriate antimicrobials, starting in the meantime with some nutritional immune supplement.


What more can one do in a “democratic”  society where TB obviously cannot be notified without good evidence, and HIV-AIDS  is apparently still not a compulsorily notifiable disease ante mortem?


The diet of the poor or the ignorant – sugar, low nutritional value food,  and often smoking,  excess alcohol and stress, poor living/work  conditions, and lack of exercise –  often with little or no restful  sleep, fresh air, fresh produce or fish – promotes both infections and chronic degenerative disease, such as cancer,  diabetic- vascular, mental, arthritis and osteoporosis, because  such  lifestyle and  stressed aging creatures  are  deficient, imbalanced  in essential protective antioxidant  immunomodulating  anabolic  vitamins minerals and biologicals  eg  marine fatty acids, co-Q10, acetylcysteine, carnitine, hormones  and scores others.


It is common cause that the exhausted depleted body is far less able to prevent and  fight disease than the healthy are, whether against common colds or tuberculosis and cancer. One has only to think of  fever blisters, shingles, tuberculosis,  hypertension  or heart attack that are more prevalent in the stressed and nutritionally imbalanced;  and the fact that  the seriously ill are admitted to hospitals or sanatoria  – or given both food packages and drugs- for both balanced diet and modern therapy.


It is common cause – amongst sensible natural healers (sangomas), homeopaths and naturopaths as well as the medically qualified –  that it is folly to ignore antibiotics or modern therapies/ surgery with serious diseases where these are known to be responsive to antimicrobials, chemo-and radiotherapy. While designer modern synthetic antimicrobial, anticancer and anticardiovascular disease therapy may have major adverse effects, there is no contesting that they have major benefits in acute illness, especially when combined with appropriate macro- and micro-nutrition.


Drastic  modern high-tech  therapies are also   futile, unlikely to prolong life long  if underlying major malnutrition- obesity  with micronutrient imbalance, or starvation- are not simultaneously addressed. And designer drug companies are well aware that prescription drugs need to be supplemented where appropriate eg Viagra with testosterone, statins with CoQ10, anti-diabetics with alpha-lpoic acid , antibiotics with vitamins and pre/probiotics, NSAIDs with gastroprotectives  etc.

For cancer the evidence is comprehensively summed up at: Dietary Supplements in Patients With Cancer: Risks and Key Concepts, Part 2 Laura Boehnke Michaud, Julie Phillips Karpinski, Kellie L. Jones and Janet Espirito: Am J Health-Syst Pharm.  2007;64:467-480. 

For evidence in a broader context:    see  2008 Harvard Special Report on “Vitamins and Minerals: What you need to know.”

The South African Academy of Science recently released a massive three year  literature search report focusing on the controversy around  HIV, TB and nutrition, affirming that   “no component of food has yet been identified in any credible scientific study as being an effective substitute for appropriate antimicrobial agents when indicated for the treatment of HIV  or active tuberculosis infection. This does not in any way imply, however, that nutritional intervention has no role in the integrated management of these infections, especially in developing countries where nutritional deficiencies are also rife. “.
     Modern science  (funded mostly  by investors, entrepeneurs – not often by altruistic billionaires) has been slow, reluctant  to validate by scientific trials  the difficult-to-disprove  therapies that Linus Pauling  (and even Hahnemann and Rudolph Steiner) and  their  students promote(d) .


In particular, major studies from Toronto Canada,  and  Harvard University- Dar es Salaam Tanzania,   in 2006 showed striking  2 to 3 fold reductions in mortality from HIV and TB when ANTIMICROBIALS were supplemented with especially betacarotene  120  000 iu/day or zinc 45mg/day , let alone  iron, selenium, vitamin C,  D  and E,  amongst other minerals and vitamins  in both endemically deprived patients (Tanzania)  and western patients (Canada). 


In progressive  adult diseases like smoking  or alcoholism damage, overweight, diabetes  TB, HIV,  or  hypertension, it is folly, negligence not to diagnose and comprehensively treat early, whether just with lifestyle , or metformin or antimicrobials  or antihypertensives respectively. 


So the outcry against those who publically oppose all patented antimicrobial drugs  for eg HIV   is valid.  But as the Academy of Science has pronounced, this is not to  condemn prescription and provision of  good nutrition and proven appropriate natural  therapeutic supplements – which are  the original and often still the best medicines.

       The Cape Court judgement so far published carefully does not venture into this well-proven scientific area – nor pronounce judgement against the current Government  under  the ANC’s Presidents Mbeki and Zuma for it’s progressive impoverishment  and (by default of adequate funding and control of the police) permitted terrorization of the masses the past decade in favour of useless weapons, institutionalized  corruption and violence, and massive enrichment of the favoured bureaucrats and cadres as in Zimbabwe.. (lest it be forgotten, Mr Zuma was deputy president of South Africa from 1998 to 2004 ie from  when the  infinitely corrupt and avoidable Armsgate,  Eskom  and South African Airways insolvency disasters were forced  by the ANC Govt  on South Africa against massive public protests, that have ruined South  and thus southern Africa.).

“The Cape court did not find that Rath’s distribution of his products was unlawful merely because they are distributed. What was deemed to be unlawful were the claims  made in advertisements associated with Rath’s product distribution, i.e. the claims that rendered VitaCell a medicine. The court therefore interdicted the Rath respondents from making claims that VitaCell reverses the course of AIDS.

     In reaching a decision on the second question, whether Rath and his accomplices were found to have conducted unauthorised clinical trials, the Court ventured into new legal terrain because “the term ‘clinical trial’ has never been judicially considered in South Africa” (para 72). In the absence of relevant South African case law, the Court considered a 2002 decision of the Zimbabwean Supreme Court where “clinical trial” was defined as:  “a systematic study in human beings or animals to establish the efficacy of, or to discover or verify the effects or adverse reactions of drugs” Importance of the judgment   “Many people in South Africa still present far too late to the public health system, with advanced AIDS. Many patients try all kinds of alternative remedies before finally seeking help from their local clinics. Many never take the opportunity to live longer, healthier lives by using scientifically proven antiretroviral medicines because they are hoodwinked into trying unproven elixirs. Charlatans and quacks abound; some of the more notorious  claim garlic , Ozone Rectal Therapy, and an African potato solution treat numerous diseases.  The Minister of Health has fostered this situation by creating the illusion that people with HIV have a reasonable choice to make between antiretrovirals versus alternative remedies and by failing to enforce the Medicines Act.   Charlatans operate in every society, but they usually operate on the fringes. In South Africa, charlatanism has become mainstream. This judgment has unequivocally established that the Minister of Health has a duty to enforce the Medicines Act and to uphold the scientific governance of medicine. “


Some other  references:

2007 DSEA REPORT SHOWS  HUGE HEALTHCARE SAVINGS: The final report of a study commissioned by the Dietary Supplement Education Alliance (DSEA) shows that  over the next five years, appropriate use of certain dietary supplements could improve the health of key populations and save more than $24 billion in healthcare costs. Ie >$10 000 per person per year.

Among the key findings were that:

 calcium with vitamin D could save $16,1 billion by avoiding hospital care for hip fractures;

 folic acid could save $1,4 billion by preventing neural tube defects;

 omega 3 fatty acids could save over $3,2 billion by reducing coronary heart disease in the over-65s;

 and lutein with zeaxanthin could save $3,6 billion by helping people with age-related macular degeneration avoid dependency on community nursing care. 

Infections during severe primary undernutrition and subsequent refeeding: paradoxical findings. Aust N Z J Med. 1995 ;25:507-11Murray MJ, Murray AB, Murray NJ, Murray MB. University of Minnesota,
BACKGROUND: Our earlier uncontrolled observations during primary famine and subsequent refeeding did not suggest that severe undernutrition inevitably increases vulnerability to infection. Some infections appeared suppressed by famine but reactivated by refeeding. AIMS: To examine prospectively the occurrence of infections in a large cohort of primary famine victims before and during refeeding. METHODS: From 1973 to 1993, 4382 famine victims aged 14 or more with an estimated weight loss greater than 25% were weighed and examined for infection before and after one, two, three and four weeks of refeeding. In 137, serum C-reactive protein was measured in an effort to detect latent asymptomatic infections before and after two weeks of refeeding. Refeeding diets included wheat, sorghum, millet, ghee and milk powder. RESULTS: Mean weight loss +/- SD was 28.7 +/- 2.3%. Before refeeding overt infections were found in 4.9%, an incidence rising to 29.1% at two weeks of refeeding.

The slow discovery of the importance of omega 3 essential fatty acids in human health. J Nutr. 1998 Feb;128(2 Suppl):427S-433S.  Holman RT. University of Minnesota,.
Although linoleic and linolenic acids have been known to be necessary for normal growth and dermal function since 1930, the omega 3 essential fatty acids (EFA) have not received much attention until recently. The two families of acids are metabolized by the same enzymes, making them competitive. Gross deficiencies of omega 6 plus omega 3 EFA have been observed in humans, induced by attempts at total parenteral nutrition (TPN) with preparations devoid of lipids. Deficiency of omega 3 acids has been induced by TPN containing high omega 6 and low omega 3 fatty acids. In natural human populations, a wide range of omega 3 and omega 6 proportions have been found, ranging from high omega 3 and low omega 6 content to low omega 3 and high omega 6 content, showing inverse correlation between sigma omega 6 and sigma omega 3. In humans with neuropathy or impairment of the immune system, significant deficits of omega 3 EFA have been measured.

Diabetes Metab. 2003 Dec;29(6):635-42. Fish-seafood consumption, obesity, and risk of type 2 diabetes: an ecological study.
Nkondjock A, Receveur O.   Research Centre, CHUM-Hôtel-Dieu,  Montreal, Quebec, Canada H2W 1T7.

OBJECTIVES: There is substantial evidence that type 2 diabetes increases with the degree and duration of obesity. This study was conducted to examine the association, at the international level, between fish and seafood consumption and the prevalence of type 2 diabetes, taking into account the prevalence of obesity. METHODS: An ecological study of 41 countries in five continents with different socio-demographic characteristics and sanitary conditions was carried out. Data on the prevalence of diabetes and obesity as well as food balance sheets were collected from websites. Correlations between the variables studied were followed by an exploration of their interaction. RESULTS: After adjustment for total energy intake, there was a significant correlation (rho=0.81, P<0.0001) between the prevalence of type 2 diabetes in the 20- to 44- and 45- to 64-year age groups. Type 2 diabetes in the 45- to 64-year age group was about 5 times higher than in the 20- to 44-year age group. Obesity was positively associated with type 2 diabetes in both age groups (rho=0.39; P=0.012 and rho=0.48; P=0.002 in the 20- to 44- and 45- to 64-year age groups, respectively). An interaction effect was found between diabetes, obesity and total fish and seafood consumption. In countries with low fish and seafood consumption, the prevalence of type 2 diabetes increased significantly with obesity (0.8 +/- 0.3% vs. 2.5 +/- 1.8%; P=0.002 and 3.3 +/- 2.6% vs. 11.0 +/- 3.9%; P<0.0001 for the 20- to 44- and 45- to 64-year age groups, respectively). In countries with a greater prevalence of obesity, there was evidence of significantly reduced type 2 diabetes with high fish and seafood consumption (2.5 +/- 1.8% vs. 0.9 +/- 0.7%; P=0.007 and 11.0 +/- 3.9% vs. 6.2 +/- 4.1%; P=0.041 for the 20- to 44- and 45- to 64-year age groups, respectively). CONCLUSION: The results of this study suggest that high fish and seafood intake may reduce the risk of type 2 diabetes in populations with a high prevalence of obesity.

Circulation. 2003 Apr 15;107(14):1852-7. Epub 2003 Mar 31.
Fish and long-chain omega-3 fatty acid intake and risk of coronary heart disease and total mortality in diabetic women.
Hu FB, Cho E, Rexrode KM, Albert CM, Manson JE.Harvard School of Public Health,  Boston, Mass
BACKGROUND: Although several prospective cohort studies have found an inverse association between fish consumption and risk of coronary heart disease (CHD) or sudden cardiac death in the general population, limited data are available among diabetic patients. METHODS AND RESULTS: We examined prospectively the association between intake of fish and omega-3 fatty acids and risk of CHD and total mortality among 5103 female nurses with diagnosed type 2 diabetes but free of cardiovascular disease or cancer at baseline. Between 1980 and 1996 (45 845 person-years of follow-up), we documented 362 incident cases of CHD (141 CHD deaths and 221 nonfatal myocardial infarctions) and 468 deaths from all causes. Compared with women who seldom consumed fish (<1 serving/mo), the relative risks (RRs) (95% CI) of CHD adjusted for age, smoking, and other established coronary risk factors were 0.70 (0.48 to 1.03) for fish consumption 1 to 3 times per month, 0.60 (0.42 to 0.85) for once per week, 0.64 (0.42 to 0.99) for 2 to 4 times per week, and 0.36 (0.20 to 0.66) for 5 or more times per week (P for trend=0.002). Higher consumption of fish was also associated with a significantly lower total mortality (multivariate RR=0.48 [0.29 to 0.80] for > or =5 times per week [P for trend=0.005]). Higher consumption of long-chain omega-3 fatty acids was associated with a trend toward lower incidence of CHD (RR=0.69 [95% CI 0.47 to 1.03], P for trend=0.10) and total mortality (RR=0.63 [95% CI, 0.45 to 0.88], P for trend=0.02). CONCLUSIONS: A higher consumption of fish and long-chain omega-3 fatty acids was associated with a lower CHD incidence and total mortality among diabetic women.

Arch Neurol. 2006 Oct;63(10):1402-8.
Omega-3 fatty acid (DHA : EPA 3:1)  treatment in 174 patients with mild to moderate Alzheimer disease: Omeg  AD study: a randomized double-blind trial.

Freund-Levi Y
, Palmblad J ea. Karolinska University Hospital Stockholm.
BACKGROUND: Epidemiologic and animal studies have suggested that dietary fish or fish oil rich in omega-3 fatty acids, for example, docosahexaenoic acid and eicosapentaenoic acid, may prevent Alzheimer disease (AD). OBJECTIVE: To determine effects of dietary omega-3 fatty acid supplementation on cognitive functions in patients with mild to moderate AD. DESIGN: Randomized, double-blind, placebo-controlled clinical trial. PARTICIPANTS: Two hundred four patients with AD (age range [mean +/- SD], 74 +/- 9 years) whose conditions were stable while receiving acetylcholine esterase inhibitor treatment and who had a Mini-Mental State Examination (MMSE) score of 15 points or more were randomized to daily intake of 1.7 g of docosahexaenoic acid and 0.6 g of eicosapentaenoic acid (omega-3 fatty acid-treated group) or placebo for 6 months, after which all received omega-3 fatty acid supplementation for 6 months more. MAIN OUTCOME MEASURES: The primary outcome was cognition measured with the MMSE and the cognitive portion of the Alzheimer Disease Assessment Scale. The secondary outcome was global function as assessed with the Clinical Dementia Rating Scale; safety and tolerability of omega-3 fatty acid supplementation; and blood pressure determinations. RESULTS: One hundred seventy-four patients fulfilled the trial. At baseline, mean values for the Clinical Dementia Rating Scale, MMSE, and cognitive portion of the Alzheimer Disease Assessment Scale in the 2 randomized groups were similar. At 6 months, the decline in cognitive functions as assessed by the latter 2 scales did not differ between the groups. However, in a subgroup (n = 32) with very mild cognitive dysfunction (MMSE >27 points), a significant (P<.05) reduction in MMSE decline rate was observed in the omega-3 fatty acid-treated group compared with the placebo group. A similar arrest in decline rate was observed between 6 and 12 months in this placebo subgroup when receiving omega-3 fatty acid supplementation. The omega-3 fatty acid treatment was safe and well tolerated. CONCLUSIONS: Administration of omega-3 fatty acid in patients with mild to moderate AD did not delay the rate of cognitive decline according to the MMSE or the cognitive portion of the Alzheimer Disease Assessment Scale. However, positive effects were observed in a small group of patients with very mild AD (MMSE >27 points).


Med Hypotheses. 2007;69::8-11.  Lithium and antidepressants: stimulating immune function and preventing and reversing infection. Lieb J.     The ability to safely and economically stimulate immune function would transform the humanitarian and economic landscapes of nosocomial, surgical and antibiotic-resistant infections, as well as reduce the burden of epidemics, pandemics and bioterrorism. Such stimulation is widely held to be beyond our reach, an unfortunate misconception. As early as the mid 1980s sufficient evidence had accumulated to be able to state with conviction that lithium and antidepressants have these properties. Excessive production of prostaglandin E2 activates microorganisms and suppresses immune function, and lithium and antidepressants oppose prostaglandin E2. Immunostimulation is non-specific, possibly relevant to all infections, pertinent to one, two, or more concurrent infections, and highly cost/effective. In controlled studies an antidepressant would be relevant to that agent and only that agent, rendering such studies worthless. Over the past twenty years 22 drug companies have declined interest in developing antidepressants as anti-infectives. It would be unethical to deny the infected these well documented benefits. 

Pharmacotherapy. 1996 Nov-Dec;16(6):1070-5.

Suppression of herpes simplex virus infections with oral lithium carbonate–a possible antiviral activity.  Amsterdam JD, Maislin G, Hooper MB. University of Pennsylvania
In vitro studies have shown an inhibitory effect of lithium salts on herpes simplex virus (HSV) replication by mechanisms that interfere with viral DNA synthesis. Moreover, clinical studies have shown that oral lithium carbonate and topical lithium succinate can suppress genital HSV infections in humans. We conducted a randomized, double-blind, placebo-controlled trial of oral lithium carbonate in 11 healthy subjects age 28-65 years (mean +/- SD age 38 +/- 11 years) who had at least four recurrent HSV infections in the year preceding the study. Six patients completed at least 5 months of lithium therapy at a mean (+/-SD) average daily lithium dose of 437 +/- 185 mg (range, 150-900 mg) and an average serum lithium level of 0.56 +/- 0.20 mmol/L. Overall, lithium treatment resulted in a consistent reduction in the mean number of episodes/month, the average duration of each episode, the total number of infection days/month, and the maximum symptom severity. In contrast, treatment with placebo resulted in an increase in three out of the four severity measures. Although the comparisons between the treatment groups did not achieve statistical significance due to the limited sample size, there was a clear “trend” for a reduction in the total monthly duration of all HSV infections with lithium (p = 0.08). Lithium treatment was well tolerated and produced no deleterious effects on renal or thyroid function. These observations lend support to prior observations of an antiviral activity of lithium, and suggest the possibility that oral lithium may represent a safe prophylactic agent in patients with recurrent HSV infections.
N Engl J Med. 1980 Jan 31;302(5):257-60.

The use of lithium carbonate to reduce infection and leukopenia during systemic chemotherapy. Lyman GH, Williams CC, Preston D.
To investigate whether lithium ameliorates the infectious complications that accompany systemic chemotherapy, we studied 45 patients with small-cell bronchogenic carcinoma receiving combination chemotherapy and radiation therapy. Twenty received lithium carbonate, and 25 received no additional therapy. Control subjects experienced more days with neutropenia than the lithium-treated group (2.17 days per 100 patient-days vs. 0.29), more severe febrile episodes (seven patients vs. one patient), more days hospitalized with fever and neutropenia (1.92 per 100 patient-days vs. 0.18), and more infection-related deaths (five vs. none). Infection-free survival was significantly longer in the lithium-treated group than in controls (P less than 0.05). Delay in subsequent chemotherapy was longer (P less than 0.01) and the number of dose reductions greater (P less than 0.01) in the control group. For both leukocytes and neutrophils, the first cycle nadir, mean of all treatment nadirs, and the lowest nadir observed during treatment were significantly higher in the lithium group. Mean mid-cycle monocyte counts were greater in the lithium group (P less than 0.05) and correlated with concurrent serum lithium levels (rs = 0.74, P less than 0.05). We believe that lithium carbonate shows promise as a means of lowering the risk of infection among patients receiving cytotoxic therapy.

Nutrients and HIV: Part Three – N-Acetylcysteine, Alpha-Lipoic Acid, L-Glutamine, and L-Carnitine

The Importance of Redox Homeostasis in HIV Lyn Patrick, ND (Altern Med Rev 2000;5(4):290-305)

HIV infection and the progression to AIDS involves a long period of latent infection characterized by low levels of viral replication that slowly increase to the point of immunosuppression. The role of antioxidants in preventing apoptosis and viral activation in HIV is well documented. N-acetylcysteine, glutathione, and alpha-lipoic acid have been shown to interrupt the process of viral activation and CD4 cell death. L-glutamine has been shown to improve glutathione levels and significantly increase lean body mass in HIV infection.

The literature on the use of L-carnitine and acetyl-L-carnitine in treating mitochondrial toxicity, both in muscle and nerve pathologies is relevant in nutritional treatment of HIV, given the mitochondrial toxicity of nucleoside analog reverse transcriptase inhibitor therapy. The current use of highly-active antiviral therapies, their toxicity, and significant failure rates have created the need for a more conservative reassessment of HIV treatment. The adjunctive use of nutrient therapy in the treatment of HIV is reviewed here.

Lancet. 2001 Sep 1;358(9283):696-701.

Effect of preoperative oral immune-enhancing nutritional supplement on patients at high risk of infection after cardiac surgery: a randomised placebo-controlled trial.
Tepaske R
, Kesecioglu J ea. University of Amsterdam, Netherlands.
BACKGROUND: Elderly patients and those with poor ventricular function have increased morbidity and mortality rates when undergoing surgery. We aimed to ascertain whether an oral immune-enhancing nutritional supplement could improve preoperative host defence, and subsequently lower postoperative infections and organ dysfunction in patients undergoing elective cardiac surgery who are at high risk of infection. METHODS: In this prospective, randomised, double-blind, placebo-controlled study, we randomly assigned 50 patients who were scheduled to undergo coronary artery bypass to receive either an oral immune-enhancing nutritional supplement containing L-arginine, omega3 polyunsaturated fatty acids, and yeast RNA (n=25), or a control (n=25) for a minimum of 5 days. Patients were included if they were aged 70 years or older, or had an ejection fraction of less than 0.4, or were scheduled to undergo mitral valve replacement. The main outcome was preoperative host defence (delayed-type hypersensitivity response to recall antigens, expression of HLA-DR epitopes on monocytes, and concentration of interleukin 6 in plasma). Analysis was per protocol. FINDINGS: Five patients (two in the treatment group) were excluded because they did not take the minimum dose. Preoperative expression of HLA-DR epitopes on monocytes was significantly higher in patients given the study treatment (109% [95% CI 92-128]) than those given the control (69% [58-82]) compared with baseline (100%) (p=0.02, repeated measures ANOVA). However, concentration of interleukin 6 was significantly lower in the treatment group (0.90 pg/L [0.69-1.18]) than in the control group (1.94 pg/L [1.45-2.59]) (p=0.032, repeated measures ANOVA). Additionally, delayed-type hypersensitivity response to recall antigens improved preoperatively and remained better until hospital discharge. INTERPRETATION: Intake of an oral immune-enhancing nutritional supplement for a minimum of 5 days before surgery can improve outlook in high-risk patients who are undergoing elective cardiac surgery.

Arch Surg. 1999 Apr;134(4):428-33. . Braga M, , Di Carlo V ea Scientific Institute San Raffaele Hospital, Milan, Italy.

Perioperative immunonutrition in patients undergoing cancer surgery: results of a randomized double-blind phase 3 trial. 
HYPOTHESIS: Perioperative administration of a supplemented enteral formula may reduce the rate of postoperative infections. DESIGN: Prospective, randomized, double-blind clinical trial. SETTING: Department of surgery at a university hospital. PATIENTS: Two hundred six patients with neoplasm of colorectum, stomach, or pancreas. INTERVENTION: Patients were randomized to drink 1 L/d of either a control enteral formula (n = 104) or the same formula enriched with arginine, RNA, and omega3 fatty acids (n = 102) for 7 consecutive days before surgery. The 2 diets were isoenergetic and isonitrogenous. Jejunal infusion with the same formulas was started 6 hours after operation and continued until postoperative day 7. MAIN OUTCOME MEASURES: Rate of postoperative infectious complications and length of hospital stay. RESULTS: Both groups were comparable for age, sex, weight loss, Karnofsky scale score, nutritional status, hemoglobin level, duration of surgery, blood loss, and rate of homologous transfusion. Intent-to-treat analysis showed a 14% (14/102) infectious complication rate in the supplemented group vs 30% (31/104) in the control group (P = .009). In the eligible population, the postoperative infection rate was 11% (9/85) in the supplemented group vs. 24% (21/86) in the control group (P = .02). The mean +/- SD length of postoperative stay was 11.1+/-4.4 days in the supplemented group and 12.9+/-4.6 in the control group (P = .01). CONCLUSION: Perioperative administration of a supplemented enteral formula significantly reduced postoperative infections and length of stay in patients undergoing surgery for cancer

Crit Care Med. 2007;35:118-26.

Selenium in Intensive Care (SIC): results of a prospective randomized, placebo-controlled, multiple-center study in patients with severe systemic inflammatory response syndrome, sepsis, and septic shock. Angstwurm MWGärtner R. ea  Ludwig-Maximilians Universität München, Germany.
OBJECTIVE: Sepsis is associated with an increase in reactive oxygen species and low endogenous antioxidative capacity. We postulated that high-dose supplementation of sodium-selenite would improve the outcome of patients with severe sepsis and septic shock. DESIGN: Prospective randomized, placebo-controlled, multiple-center trial. SETTING: Eleven intensive care units in Germany. PATIENTS: Patients were 249 patients with severe systemic inflammatory response syndrome, sepsis, and septic shock and an Acute Physiology and Chronic Health Evaluation (APACHE) III score >70. INTERVENTIONS: Patients received 1000 microg of sodium-selenite as a 30-min bolus injection, followed by 14 daily continuous infusions of 1000 microg intravenously, or placebo. MEASUREMENTS AND MAIN RESULTS: The primary end point was 28-day mortality; secondary end points were survival time and clinical course of APACHE III and logistic organ dysfunction system scores. In addition, selenium levels in serum, whole blood, and urine as well as serum glutathione-peroxidase-3 activity were measured. From 249 patients included, 11 patients had to be excluded. The intention-to-treat analysis of the remaining 238 patients revealed a mortality rate of 50.0% in the placebo group and 39.7% in the selenium-treated group (p = .109; odds ratio, 0.66; confidence interval, 0.39-1.1). A further 49 patients had to be excluded before the final analysis because of severe violations of the study protocol. In the remaining 92 patients of the study group, the 28-day mortality rate was significantly reduced to 42.4% compared with 56.7% in 97 patients of the placebo group (p = .049, odds ratio, 0.56; confidence interval, 0.32-1.00). In predefined subgroup analyses, the mortality rate was significantly reduced in patients with septic shock with disseminated intravascular coagulation (n = 82, p = .018) as well as in the most critically ill patients with an APACHE III score > or =102 (>75% quartile, n = 54, p = .040) or in patients with more than three organ dysfunctions (n = 83, p = .039). Whole blood selenium concentrations and glutathione peroxidase-3 activity were within the upper normal range during selenium treatment, whereas they remained significantly low in the placebo group. There were no side effects observed due to high-dose sodium-selenite treatment. CONCLUSIONS

: The adjuvant treatment of patients with high-dose sodium-selenite reduces mortality rate in patients with severe sepsis or septic shock.


2007;356:1423-31.Vitamins and perinatal outcomes among HIV-negative women in Tanzania. Fawzi WW, Willett WC, Spiegelman D ea.  Harvard N Engl J Med.

BACKGROUND: Prematurity and low birth weight are associated with high perinatal and infant mortality, especially in developing countries. Maternal micronutrient deficiencies may contribute to these adverse outcomes. METHODS: In a double-blind trial in Dar es Salaam, Tanzania, we randomly assigned 8468 pregnant women (gestational age of fetus, 12 to 27 weeks) who were negative for human immunodeficiency virus infection to receive daily multivitamins (including multiples of the recommended dietary allowance) or placebo. All the women received prenatal supplemental iron and folic acid. The primary outcomes were low birth weight (<2500 g), prematurity, and fetal death. RESULTS: The incidence of low birth weight was 7.8% among the infants in the multivitamin group and 9.4% among those in the placebo group (relative risk, 0.82; 95% confidence interval [CI], 0.70 to 0.95; P=0.01). The mean difference in birth weight between the groups was modest (67 g, P<0.001). The rates of prematurity were 16.9% in the multivitamin group and 16.7% in the placebo group (relative risk, 1.01; 95% CI, 0.91 to 1.11; P=0.87), and the rates of fetal death were 4.3% and 5.0%, respectively (relative risk, 0.87; 95% CI, 0.72 to 1.05; P=0.15). Supplementation reduced both the risk of a birth size that was small for gestational age (<10th percentile; 10.7% in the multivitamin group vs. 13.6% in the placebo group; relative risk, 0.77; 95% CI, 0.68 to 0.87; P<0.001) and the risk of maternal anemia (hemoglobin level, <11 g per deciliter; relative risk, 0.88; 95% CI, 0.80 to 0.97; P=0.01), although the difference in the mean hemoglobin levels between the groups was small (0.2 g per deciliter, P<0.001). CONCLUSIONS: Multivitamin supplementation reduced the incidence of low birth weight and small-for-gestational-age births but had no significant effects on prematurity or fetal death. Multivitamins should be considered for all pregnant women in developing countries.

Acta Obstet Gynecol Scand.

2007;86:783-7. Ochoa-Brust GJ, Vásquez C.e Universidad de Colima, México  Daily intake of 100 mg ascorbic acid as urinary tract infection prophylactic agent during pregnancy..
OBJECTIVE: To evaluate the role a daily intake of 100 mg of ascorbic acid plays in urinary infection prophylaxis during pregnancy. METHODS AND MATERIALS: A single-blind clinical trial was carried out on pregnant women randomly assigned to the following treatment groups – Group A: oral treatment with ferrous sulphate (200 mg per day), folic acid (5 mg per day) and ascorbic acid (100 mg per day) for 3 months, and Group B: oral treatment with ferrous sulphate (200 mg per day) and folic acid (5 mg per day) for 3 months. All patients were clinically evaluated, and a urine culture was carried out each month for a period of 3 months. The chi(2) and odds ratio were used to compare effects with and without ascorbic acid, and statistical significance was considered at p<0.05. RESULTS: Global frequency of urinary infections was 25%. The presence of urinary infections in Group A (12.7%) was significantly lower than in Group B (29.1%), (p=0.03, OR =0.35, CI 95% =0.13-0.91). CONCLUSIONS: Daily intake of 100 mg of ascorbic acid played an important role in the reduction of urinary infections, improving the health level of the gestating women. We recommend additional vitamin C intake for pregnant women in populations which have a high incidence of bacteriuria and urinary infections.
Hepatogastroenterology. 2007 ;54:320-4. Chuang CH, Wu JJ. Adjuvant effect of vitamin C on omeprazole-amoxicillin-clarithromycin triple therapy for Helicobacter pylori eradication. National Cheng Kung University, Taiwan.
 BACKGROUND/AIMS: To test the impact of vitamin C supplementation on triple therapy for H. pylori eradication. METHODOLOGY: A total of 171 H. pylori-infected patients were randomized to receive different one-week triple therapies, including 20 mg omeprazole, 1 g amoxicillin, plus the following twice daily: (1) 250 mg clarithromycin (C250 group, n=55); (2) 250 mg clarithromycin and 500 mg vitamin C (V-C250 group, n=61); (3) 500 mg clarithromycin (C500 group, n=55). Six weeks after treatment, the success of H. pylori eradication was assessed by a 13C-urea breath test. Each collected H. pylori strain was defined as either clarithromycin susceptible or resistant by E-test. RESULTS: The demographic background, clarithromycin susceptibility of H. pylori, and drug compliance were similar among the three groups (p=NS). For clarithromycin susceptible infection, the V-C250 group had a higher eradication rate than the C250 group (ITT: 85% vs. 68% and PP: 90% vs. 73%, p = 0.03), but had an equivalent rate to the C500 group (p=NS). For clarithromycin resistant infection, all three groups had a similarly poor eradication rate of less than 34%. CONCLUSIONS: Adding vitamin C to one-week triple therapy can reduce the dosage of clarithromycin, but preserve the high eradication efficacy for clarithromycin susceptible H. pylori infection.


Eur J Clin Nutr. 2006;60:1266-76. community randomized controlled clinical trial of mixed carotenoids and micronutrient supplementation of patients with acquired immunodeficiency syndrome.  Austin J, Cameron DW; ea CTN 091/CRIT Cartenoids Study Group. Community Research Initiative Toronto, Canada.
OBJECTIVE: This clinical trial aims to evaluate if natural mixed carotenoids supplementation can improve the health and survival of acquired immunodeficiency syndrome (AIDS) patients. DESIGN: A placebo-controlled, prospective, randomized, double-blind, multicenter clinical trial. SETTING: Community, tertiary care human immunodeficiency virus (HIV) clinics of the Canadian HIV Trials Network (CTN). PARTICIPANTS: Three hundred and thirty-one adults with advanced AIDS on conventional management were recruited during routine clinic visits. INTERVENTIONS: All participants, including 166 controls, received daily oral specially formulated multivitamins including vitamin A and trace elements; 165 treatment group participants received additional daily oral natural mixed carotenoids, equivalent to 120,000 IU (72 mg) of beta-carotene daily. Follow-up was quarterly at routine clinic visits. RESULTS: Mean (s.d.) follow-up was for 13 (6) months. Thirty-six participants died by 18 months. Serum carotene concentration <1.0 micromol/l was present in 16% participants at baseline. Despite variation in carotene content of the treatment medication, serum carotene concentrations increased significantly to twice the baseline levels to 18 months follow-up in participants who received carotenoids treatment compared with controls (P < 0.0001). Although not statistically significant, mortality was increased in participants who did not receive carotenoids treatment compared with those who did (HR time to death 1.76, 95% CI 0.89, 3.47, P = 0.11). In multivariate analysis, survival was significantly and independently improved in those with higher baseline serum carotene concentrations (P = 0.04) or higher baseline CD4 T-lymphocyte counts (P = 0.005). Adjusted mortality was also significantly and independently increased in those who did not receive carotenoids treatment compared with those who did (HR time to death 3.15, 95% CI 1.10, 8.98, P = 0.03). CONCLUSIONS: Low serum carotene concentration is common in AIDS patients and predicts death. Supplementation with micronutrients and natural mixed carotenoids may improve survival by correction of a micronutrient deficiency. Further studies are needed to corroborate findings and elucidate mechanism of action.

Br J Nutr. 2006 Apr;95(4):762-70. The effect of multi-vitamin/mineral supplementation on mortality during treatment of pulmonary tuberculosis: a randomised two-by-two factorial trial in Mwanza, Tanzania. Range N, Friis H. ea National Institute for Medical Research, Dar es Salaam, Tanzania.
Malnutrition is common in pulmonary tuberculosis (TB), and may impair survival. The objective of this study was to assess effects of multi-vitamin/mineral (MVM) and zinc (Zn) supplementation during TB treatment on mortality. Patients diagnosed with sputum-positive pulmonary TB in Mwanza, Tanzania, were randomised, using a two-by-two factorial design, to Zn (45 mg) or placebo, and MVM (vitamins A, B, C, D, E, and selenium and copper) or placebo. Survival status was ascertained at the end of the 8-month TB treatment and supplementation period. Of 499 TB patients, 213 (43 %) had HIV. The mean weight gain at 7 months was 6.88 kg (95 % CI 6.36, 7.41). Zn and MVM combined, but neither alone (interaction, P=0.03), increased weight gain by 2.37 kg (95 % CI 0.91, 3.83), irrespective of HIV status. Survival status at 8 months was determined for 422 patients (84.6 %), of which fifty-two (12.3 %) had died. Among fifty-two deaths, there were no effects of MVM (relative risk (RR) 0.73; 95 % CI 0.43, 1.23) and Zn (RR 0.76; 95 % CI 0.46, 1.28). However, among HIV co-infected patients, marginally significant effects of both MVM (RR 0.60; 95 % CI 0.34, 1.05) and Zn (RR 0.63, 95 % CI 0.37, 1.08) were seen, and MVM and Zn combined reduced mortality (RR 0.29; 95 % CI 0.10, 0.80; interaction ratio 0.52). In conclusion, supplementation with MVM, including Zn, during treatment of pulmonary TB may reduce mortality in those co-infected with HIV. A randomised trial of the effect of the combined intervention used in this study should be conducted in a different setting to confirm the finding.

Reduction of nosocomial pneumonia after major burns by trace element supplementation: aggregation of two randomised trials. Berger MM, Shenkin A.ea Crit Care. 2006;10(6):R153. Universitaire Vaudois (CHUV), Lausanne, Switzerland.
 INTRODUCTION: Nosocomial pneumonia is a major source of morbidity and mortality after severe burns. Burned patients suffer trace element deficiencies and depressed antioxidant and immune defences. This study aimed at determining the effect of trace element supplementation on nosocomial or intensive care unit (ICU)-acquired pneumonia. METHODS: Two consecutive, randomised, double-blinded, supplementation studies including two homogeneous groups of 41 severely burned patients (20 placebo and 21 intervention) admitted to the burn centre of a university hospital were combined. Intervention consisted of intravenous trace element supplements (copper 2.5 to 3.1 mg/day, selenium 315 to 380 mug/day, and zinc 26.2 to 31.4 mg/day) for 8 to 21 days versus placebo. Endpoints were infections during the first 30 days (predefined criteria for pneumonia, bacteraemia, wound, urine, and other), wound healing, and length of ICU stay. Plasma and skin (study 2) concentrations of selenium and zinc were determined on days 3, 10, and 20. RESULTS: The patients, 42 +/- 15 years old, were burned on 46% +/- 19% of body surface: the combined characteristics of the patients did not differ between the groups. Plasma trace element concentrations and antioxidative capacity were significantly enhanced with normalisation of plasma selenium, zinc, and glutathione peroxidase concentrations in plasma and skin in the trace element-supplemented group. A significant reduction in number of infections was observed in the supplemented patients, which decreased from 3.5 +/- 1.2 to 2.0 +/- 1.0 episodes per patient in placebo group (p < 0.001). This was related to a reduction of nosocomial pneumonia, which occurred in 16 (80%) patients versus seven (33%) patients, respectively (p < 0.001), and of ventilator-associated pneumonia from 13 to six episodes, respectively (p = 0.023). CONCLUSION: Enhancing trace element status and antioxidant defences by selenium, zinc, and copper supplementation was associated with a decrease of nosocomial pneumonia in critically ill, severely burned patients..

2004 ;52:3-12 .J Am Geriatr Soc.

Nutritional formula enhanced immune function and reduced days of symptoms of upper respiratory tract infection in seniors.  Langkamp-Henken BWood SM. ea University Florida, OBJECTIVES: To assess whether an experimental nutritional formula, given as a supplement, would reduce days of symptoms of upper respiratory tract infection (URTI) and affect antibody and lymphocyte proliferative responses to influenza vaccine. DESIGN: A prospective, randomized, double-blind, controlled trial was conducted between October 1999 and April 2000. SETTING: Assisted- and independent-living facilities in North Central Florida. PARTICIPANTS: Sixty-six individuals, aged 65 and older. INTERVENTION: Subjects received 8 oz/d of an experimental formula containing antioxidants, zinc, selenium, fermentable oligosaccharides, and structured triacylglycerol or an isoenergetic, isonitrogenous control formula for 183 days. MEASUREMENTS: Subjects recorded daily symptoms of URTI. Antibody titers and lymphocyte proliferation to three influenza vaccine components were measured on Days 57 and 183. RESULTS: Eighteen subjects in the control group and 16 subjects in the experimental group consumed an average of 7 ounces of formula daily and completed the 183-day study. Median days of symptoms of URTI were 3 (range 0-69, total days=156) and 0 (range 0-49, total days=78) for the control and experimental groups, respectively (P=.049). On Day 57, seven of 17 (41%) subjects in the control group and 13 of 15 (87%) subjects in the experimental group achieved a fourfold or greater increase in serum antibody titer to A/Beijing (P=.012). Lymphocyte proliferation to influenza vaccine components was greater in the experimental (median=1,365 cpm, range=0-14,955 cpm) than the control group (median=136 cpm, range=0-4,270 cpm) (P=.013). CONCLUSION: Subjects consuming an experimental nutritional formula experienced enhanced immune function and fewer days of URTI symptoms


N Engl J Med. 2004 ;351:23-32. Randomized trial of multivitamin supplements and HIV disease progression and mortality.  Fawzi WWHunter DJ. ea  Harvard School of Public Health
BACKGROUND: Results from observational studies suggest that micronutrient status is a determinant of the progression of human immunodeficiency virus (HIV) disease. METHODS: We enrolled 1078 pregnant women infected with HIV in a double-blind, placebo-controlled trial in Dar es Salaam, Tanzania, to examine the effects of daily supplements of vitamin A (preformed vitamin A and beta carotene), multivitamins (vitamins B, C, and E), or both on progression of HIV disease, using survival models. The median follow-up with respect to survival was 71 months (interquartile range, 46 to 80). RESULTS: Of 271 women who received multivitamins, 67 had progression to World Health Organization (WHO) stage 4 disease or died–the primary outcome–as compared with 83 of 267 women who received placebo (24.7 percent vs. 31.1 percent; relative risk, 0.71; 95 percent confidence interval, 0.51 to 0.98; P=0.04). This regimen was also associated with reductions in the relative risk of death related to the acquired immunodeficiency syndrome (0.73; 95 percent confidence interval, 0.51 to 1.04; P=0.09), progression to WHO stage 4 (0.50; 95 percent confidence interval, 0.28 to 0.90; P=0.02), or progression to stage 3 or higher (0.72; 95 percent confidence interval, 0.58 to 0.90; P=0.003). Multivitamins also resulted in significantly higher CD4+ and CD8+ cell counts and significantly lower viral loads. The effects of receiving vitamin A alone were smaller and for the most part not significantly different from those produced by placebo. Adding vitamin A to the multivitamin regimen reduced the benefit with regard to some of the end points examined. CONCLUSIONS: Multivitamin supplements delay the progression of HIV disease and provide an effective, low-cost means of delaying the initiation of antiretroviral therapy in HIV-infected women.

Int J Psychiatry Med. 2003;33(1):55-69.  Psychological burden in the era of HAART: impact of selenium therapy.  Shor-Posner G, Wilkie F. ea  University of Miami  USA.

 OBJECTIVE: To determine the impact of nutritional (selenium) chemoprevention on levels of psychological burden (anxiety, depression, and mood state) in HIV/AIDS. METHOD: A randomized, double-blind, placebo-controlled selenium therapy (200 microg/day) trial was conducted in HIV+ drug users from 1998-2000. Psychosocial measures (STAI-State and Trait anxiety, BDI-depression, and POMS- mood state), clinical status (CD4 cell count, viral load), and plasma selenium levels were determined at baseline and compared with measurements obtained at the 12-month evaluation in 63 participants (32 men, 31 women). RESULTS: The majority of the study participants reported elevated levels of both State (68%) and Trait (70%) anxiety. Approximately 25% reported overall mood distress (POMS > 60) and moderate depression (BDI > 20). Psychological burden was not influenced by current drug use, antiretroviral treatment, or viral load. At the 12-month evaluation, participants who received selenium reported increased vigor (p = 0.004) and had less anxiety (State, p = 0.05 and Trait, p = 0.02), compared to the placebo-treated individuals. No apparent selenium-related affect on depression or distress was observed. The risk for state anxiety was almost four times higher, and nearly nine times greater for trait anxiety in the placebo-treated group, controlling for antiretroviral therapy, CD4 cell decline (> 50 cells) and years of education. CONCLUSIONS: Selenium therapy may be a beneficial treatment to decrease anxiety in HIV+ drug users who exhibit a high prevalence of psychological burden.

Am J Clin Nutr. 2005 Apr;81(4):859-63.Vitamin C supplementation to prevent premature rupture of the chorioamniotic membranes: a randomized trial.Casanueva E, Vadillo-Ortega F ea.   National Institute of Perinatology, Mexico City,
BACKGROUND: Vitamin C is involved in the synthesis and degradation of collagen and is important for maintenance of the chorioamniotic membranes. Inadequate availability of ascorbic acid during pregnancy has been proposed as a risk factor for premature rupture of the chorioamniotic membranes (PROM). OBJECTIVE: The objective of the study was to evaluate the effectiveness of 100 mg vitamin C/d in preventing PROM. DESIGN: A controlled double-blind trial was performed. Pregnant women (n = 126) in their 20th wk of gestation were invited; 120 accepted and were randomly assigned to 2 groups (100 mg vitamin C/d or placebo). Every 4 wk, plasma and leukocyte vitamin C concentrations were measured, and each subject was evaluated for cervicovaginal infection. The incidence of PROM was recorded for each group as an indicator of the protective effect of vitamin C supplementation. RESULTS: One hundred nine patients finished the study. Mean plasma vitamin C concentrations decreased significantly throughout the pregnancy in both groups (P = 0.001), and there were no significant differences between groups. Between weeks 20 and 36, mean leukocyte vitamin C concentrations decreased from 17.5 to 15.23 microg/10(8) cells in the placebo group and increased from 17.26 to 22.17 microg/10(8) cells in the supplemented group (within- and between-group differences: P = 0.001). The incidence of PROM was 14 per 57 pregnancies (24.5%) in the placebo group and 4 per 52 pregnancies (7.69%) in the supplemented group (relative risk: 0.26; 95% CI: 0.078, 0.837). CONCLUSION:
Daily supplementation with 100 mg vitamin C after 20 wk of gestation effectively lessens the incidence of PROM.

Mymensingh Med J. 2003 Jul;12(2):120-3.

Antioxidant vitamins improves hemoglobin level in children with group a beta hemolytic streptococcal infection.  Ahmed J, Zaman MM, Ali K. National Center for Control of Rheumatic Fever and Heart Diseases, Bangladesh.
A study was done on school children infected with group A beta hemolytic streptococci to examine whether antioxidant vitamins play a role in improving the hemoglobin level. A total of 606 primary school children aged 5 to 15 years were randomly divided into two intervention groups. Group 1 (n=299) was treated with pehnoxymethyl penicillin V and group 2 (n=307) was treated with phenoxymethyl penicillin V plus antioxidant vitamins for eight weeks. From each group two blood samples were drawn in acute and convalescent (after eight weeks) states. Before treatment, mean hemoglobin values were 11.0 and 10.8 mg/dL in groups 1 and 2 respectively. After treatment hemoglobin values were 10.5 and 11.6 mg/dL respectively. Values were significantly decreased in group 1 (P=0.0001), whereas increased in group 2 (P=0.001). Adjustment for age and sex by ANCOVA confirmed the difference in hemoglobin levels between group (LS means-0.5 vs 0.8 in groups 1 and 2 respectively (P=0.0001). Hemoglobin level increases after antioxidant vitamin supplementation in children suffering from group A beta hemolytic streptococcal infection.

Cancer Sci. 2003 Apr;94(4):378-82.

Effect of 5-year vitamin C supplementation on serum pepsinogen level and Helicobacter pylori infection.Sasazuki S, Tsugane S. ea National Cancer Center Research Institute , Japan.
 We conducted a population-based, double-blind, randomized controlled trial to examine the effect of vitamin C supplementation on serum pepsinogen (PG) level, Helicobacter pylori (H. pylori ) infection, and cytotoxin-associated gene A (Cag A) status. Subjects aged 40 to 69 years living in one village in Akita prefecture, a high-risk area for gastric cancer in Japan, were recruited through annual health check-up programs. Among 635 subjects diagnosed as having chronic gastritis on the basis of serum PG levels, after excluding ineligible cases, 439 subjects were assigned to one of four groups using a 2 x 2 factorial design (0 or 15 mg/day beta-carotene and 50 or 500 mg/day vitamin C). However, based on the results from two beta-carotene trials in the United States, we discontinued beta-carotene (vitamin C supplementation was continued). Finally, 120 subjects in the low-dose group (vitamin C 50 mg), and 124 subjects in the high-dose group (vitamin C 500 mg) completed the 5-year supplementation. The difference in the change of PGI/II ratio between baseline and after 5-year follow up was statistically significant between the intervention groups among those who completed the supplementation: – 0.25 for the low-dose group and – 0.13 for the high-dose group (P = 0.046). To conclude, vitamin C supplementation may protect against progression of gastric mucosal atrophy.
HIV Clin Trials. 2002 Nov-Dec;3(6):483-91. Impact of a selenium chemoprevention clinical trial on hospital admissions of HIV-infected participants.Burbano X, , Shor-Posner G ea. Department of Psychiatry and Behavioral Sciences, Miami,.   PURPOSE: To evaluate the impact of selenium chemoprevention (200 microg/day) on hospitalizations in HIV-positive individuals. METHOD: Data were obtained from 186 HIV+ men and women participating in a randomized, double-blind, placebo-controlled selenium clinical trial (1998-2000). Supplements were dispensed monthly, and clinical evaluations were conducted every 6 months. Inpatient hospitalizations, hospitalization costs, and rates of hospitalization were determined 2 years before and during the trial. RESULTS: At enrollment, no significant differences in CD4 cell counts or viral burden were observed between the two study arms. Fewer placebo-treated participants were using antiretrovirals (p <.05). The total number of hospitalizations declined from 157 before the trial to 103 during the 2 year study. A marked decrease in total admission rates (RR = 0.38; p =.002) and percent of hospitalizations due to infection/100 patients for those receiving selenium was observed (p =.01). As a result, the cost for hospitalization decreased 58% in the selenium group, compared to a 30% decrease in the placebo group (p =.001). In the final analyses, selenium therapy continued to be a significant independent factor associated with lower risk of hospitalization (p =.001). CONCLUSION: Selenium supplementation appears to be a beneficial adjuvant treatment to decrease hospitalizations as well as the cost of caring for HIV-1-infected patients.


Selenium replacement in patients with severe systemic inflammatory response syndrome improves clinical outcome. Angstwurm MW, Gaertner R. ea Crit Care Med. 1999 ;27:1807-13. University of Munich, Germany.
OBJECTIVE: To determine the effect of selenium replacement on morbidity and mortality in patients with systemic inflammatory response syndrome (SIRS). DESIGN: Controlled, randomized prospective open-label pilot study comparing patients with and without selenium replacement. SETTING: Intensive care unit of a university hospital for internal medicine. PATIENTS: Forty-two patients with SIRS caused by infection and a minimal Acute Physiology and Chronic Health Evaluation (APACHE) II score of 15 points on the day of admission were included. The selenium replacement group of patients (Se+; n = 21) received sodium selenite for 9 days (535 microg [6.77 micromol] for 3 days, 285 microg [3.61 micromol] for 3 days, and 155 microg [1.96 micromol] for 3 days) and thereafter, 35 microg (0.44 micromol) per day iv. The control group (Se-, n = 21) received 35 microg of sodium selenite throughout the total treatment period. INTERVENTIONS: Morbidity and clinical outcome was monitored by scoring using the APACHE III score, occurrence of acute renal failure, need and length of mechanical ventilation, and hospital mortality. Blood samples on days 0, 3, 7, and 14 were analyzed for serum selenium concentration and glutathione peroxidase (GSH-Px) activity. MEASUREMENTS AND MAIN RESULTS: The median APACHE II score at admission, age, gender, underlying diseases, serum selenium levels, and GSH-Px activities at admission were identical in both groups. In Se+ patients, serum selenium levels and GSH-Px activity normalized within 3 days, whereas in controls, both variables remained significantly low (p < .0001). The APACHE III score decreased significantly in both groups but was significantly lower in the Se+ group (day 3, p > .05; day 7, p = .018; and day 14, p = .045 Se+ compared with Se-). Hemodialysis with continuous veno-venous hemodialysis because of acute renal failure was necessary in nine Se- compared with three Se+ patients (p = .035). Overall mortality in the Se- group was 52% vs. 33.5% in the Se+ group (p = .13). CONCLUSIONS: Selenium replacement in patients with SIRS seems to improve clinical outcome and to reduce the incidence of acute renal failure requiring hemodialysis.

Arch Intern Med. 1999;159(7):748-54.Impact of trace elements and vitamin supplementation on immunity and infections in institutionalized elderly patients: a randomized controlled trial. MIN. VIT. AOX. geriatric network.Girodon F, Herchberg S ea .Scientific and Technical Institute for Foods and Nutrition, Paris, France. BACKGROUND: Antioxidant supplementation is thought to improve immunity and thereby reduce infectious morbidity. However, few large trials in elderly people have been conducted that include end points for clinical variables. OBJECTIVE: To determine the effects of long-term daily supplementation with trace elements (zinc sulfate and selenium sulfide) or vitamins (beta carotene, ascorbic acid, and vitamin E) on immunity and the incidence of infections in institutionalized elderly people. METHODS: This randomized, double-blind, placebo-controlled intervention study included 725 institutionalized elderly patients (>65 years) from 25 geriatric centers in France. Patients received an oral daily supplement of nutritional doses of trace elements (zinc and selenium sulfide) or vitamins (beta carotene, ascorbic acid, and vitamin E) or a placebo within a 2 x 2 factorial design for 2 years. MAIN OUTCOME MEASURES: Delayed-type hypersensitivity skin response, humoral response to influenza vaccine, and infectious morbidity and mortality. RESULTS: Correction of specific nutrient deficiencies was observed after 6 months of supplementation and was maintained for the first year, during which there was no effect of any treatment on delayed-type hypersensitivity skin response. Antibody titers after influenza vaccine were higher in groups that received trace elements alone or associated with vitamins, whereas the vitamin group had significantly lower antibody titers (P<.05). The number of patients without respiratory tract infections during the study was higher in groups that received trace elements (P = .06). Supplementation with neither trace elements nor vitamins significantly reduced the incidence of urogenital infections. Survival analysis for the 2 years did not show any differences between the 4 groups. CONCLUSIONS: Low-dose supplementation of zinc and selenium provides significant improvement in elderly patients by increasing the humoral response after vaccination and could have considerable public health importance by reducing morbidity from respiratory tract infections.

AIDS. 1998 Sep 10;12:1653-9.Effects of vitamin E and C supplementation on oxidative stress and viral load in HIV-infected subjects. Allard JP, Walmsley SL ea . University of Toronto. OBJECTIVES: The HIV-infected population is known to be oxidatively stressed and deficient in antioxidant micronutrients. Since in vitro replication of HIV is increased with oxidative stress, this study assessed the effect of antioxidant vitamin supplementation on lipid peroxidation, a measure of oxidative stress, and viral load in humans. DESIGN: A randomized placebo-controlled, double-blind study. METHODS: Forty-nine HIV-positive patients were randomized to receive supplements of both DL-alpha-tocopherol acetate (800 IU daily) and vitamin C (1000 mg daily), or matched placebo, for 3 months. Plasma antioxidant micronutrient status, breath pentane output, plasma lipid peroxides, malondialdehyde and viral load were measured at baseline and at 3 months. New or recurrent infections for the 6-month period after study entry were also recorded. RESULTS: The vitamin group (n = 26) had an increase in plasma concentrations of alpha-tocopherol (P < 0.0005) and vitamin C (P < 0.005) and a reduction in lipid peroxidation measured by breath pentane (P < 0.025), plasma lipid peroxides (P < 0.01) and malondialdehyde (P < 0.0005) when compared with controls (n = 23). There was also a trend towards a reduction in viral load (mean +/- SD changes over 3 months, -0.45 +/- 0.39 versus +0.50 +/- 0.40 log10 copies/ml; P = 0.1; 95% confidence interval, -0.21 to -2.14). The number of infections reported was nine in the vitamin group and seven in the placebo group. CONCLUSION: Supplements of vitamin E and C reduce oxidative stress in HIV and produce a trend towards a reduction in viral load. This is worthy of larger clinical trials, especially in HIV-infected persons who cannot afford new combination therapies.

Biol Trace Elem Res. 1997 Jan;56(1):117-24.

Protective role of selenium against hepatitis B virus and primary liver cancer in Qidong. Yu SY, Zhu YJ, Li WG. Chinese Academy of Medical Sciences, China.
High rates of hepatitis B virus (HBV) infection and primary liver cancer (PLC) are present in Qidong county. Epidemiological surveys demonstrated an inverse association between selenium (Se) level and regional cancer incidence, as well as HBV infection. Four-year animal studies showed that dietary supplement of Se reduced the HBV infection by 77.2% and liver precancerous lesion by 75.8% of ducks, caused by exposure to natural environmental etiologic factors. An intervention trial was undertaken among the general population of 130,471. Individuals in five townships were involved for observation of the preventive effect of Se. The 8-yr follow-up data showed reduced PLC incidence by 35.1% in selenized table salt supplemented vs the nonsupplemented population. On withdrawal of Se from the treated group, PLC incidence rate began to increase. However, the inhibitory response to HBV was sustained during the 3-yr cessation of treatment. The clinical study among 226 Hepatitis B Surface Antigen (HBsAg)-positive persons provided either 200 micrograms of Se in the form of selenized yeast tablet or an identical placebo of yeast tablet daily for 4 yr showed that 7 of 113 subjects were diagnosed as having PLC in the placebo group, whereas no incidence of PLC was found in 113 subjects supplemented with Se. Again on cessation of treatment, PLC developed at a rate comparable to that in the control group, demonstrating that a continuous intake of Se is essential to sustain the chemopreventive effect.

 1997 Nov;55(11 Pt 1):400-4.  Nutr Rev. Micronutrient supplementation and infection in institutionalized elders.
Johnson MA
, Porter KH. University of Georgia, Athens 30602, USA.
A randomized, double-blind, placebo-controlled clinical trial was conducted to determine the effects of a low-dose (< 2 times the Recommended Dietary Allowance) micronutrient supplement containing trace minerals (zinc and selenium) and/or vitamins/provitamins (vitamin C, alpha-tocopherol, and beta-carotene) on the incidence of respiratory and urogenital infections in institutionalized elderly. After 2 years, there was a significant decrease in the mean number of infections in elders given trace elements (p < 0.01) but not vitamins.

Int J Vitam Nutr Res. 1994;64(3):212-9. Huddersfield University.

The clinical effects of vitamin C supplementation in elderly hospitalised patients with acute respiratory infections.Hunt C, Chakravorty NK, Annan G, Habibzadeh N, Schorah CJ.
A randomised double-blind trial involving vitamin C/placebo supplementation was conducted on 57 elderly patients admitted to hospital with acute respiratory infections (bronchitis and bronchopneumonia). Patients were assessed clinically and biochemically on admission and again at 2 and 4 weeks after admission having received either 200 mg vitamin C per day, or placebo. This relatively modest oral dose led to a significant increase in plasma and white cell vitamin C concentration even in the presence of acute respiratory infection. Using a clinical scoring system based on major symptoms of the respiratory condition, patients supplemented with the vitamin fared significantly better than those on placebo. This was particularly the case for those commencing the trial most severely ill, many of whom had very low plasma and white cell vitamin C concentrations on admission. Various mechanisms by which vitamin C could assist this type of patient are discussed.


Trop Geogr Med. 1980 Jun;32(2):132-7.  High dose ascorbic acid in Nigerian asthmatics. Anah CO, Jarike LN, Baig HA.
Forty-one asthmatic patients in remission were randomly allocated to two treatment groups in a double-blind trial. One group took 1 g, of ascorbic acid as one effervescent tablet once daily and the second group took a matching placebo. The asthmatics were selected from those attending the Asthma Clinic. One criterion for selection was the increase in exacerbation during the rainy season. These exacerbations were precipitated by respiratory infection. After 14 weeks, an assessment of the severity and rate of attacks showed that those on ascorbic acid suffered less severe and less frequent attacks of asthma during the study period. Plasma ascorbic acid astimations showed a significant rise in the level in those taking ascorbic acid over those on placebo. (P < 0.01). Cessation of ascorbic acid in the group taking it increased attack rates. It is concluded that high dose ascorbic acid is probably a good prophylaxis in some bronchial asthmatics.

J Acquir Immune Defic Syndr. 2004 ;36:637-8. Low-dose iron supplementation does not increase HIV-1 load. Olsen A, Mwaniki D, Krarup H, Friis H.Danish Bilharziasis Lab,  Denmark.
Observational data suggest that iron may increase HIV replication and the rate of progression of HIV infection. This is worrying, and may impede the international commitment to combat iron deficiency. However, it is crucial to clarify the role of iron in HIV infections, since iron is universally administered to anaemic patients and pregnant women, even in areas with high HIV prevalence. Based on a historical iron trial, we assessed the effect of 60 mg of elemental iron given twice weekly over four month on HIV-1 viral load. There was no effect on viral load, but effects of higher doses of iron cannot be excluded.

Am J Clin Nutr. 2003 Jan;77(1):234-41.  Iron supplementation improves iron status and reduces morbidity in children with or without upper respiratory tract infections: a randomized controlled study in Colombo, Sri Lanka. de Silva A, Ahluwalia N. ea University of Colombo, Sri Lanka.
BACKGROUND: Iron deficiency anemia and recurrent infections are common among children of low socioeconomic status. OBJECTIVE: The objective was to evaluate the effects of iron supplementation on iron status and morbidity in children with or without infection. DESIGN: Children aged 5-10 y were recruited for a randomized, controlled, double-blind study from outpatients attending the Children’s Hospital, Colombo, Sri Lanka. Clinical, inflammatory, nutritional, and iron statuses were determined at baseline and after the intervention. Children with a history of recurrent upper respiratory tract infections (URTIs) and with laboratory and clinical evidence of a current URTI constituted the infection group (n = 179), and children without infection constituted the control group (n = 184). Subjects in both groups were supplemented with ferrous sulfate (60 mg Fe) or placebo once daily for 8 wk. Morbidity from URTIs, the number of gastrointestinal infections, and compliance were recorded every 2 wk. RESULTS: The overall prevalence of anemia was 52.6%. Iron supplementation significantly improved iron status by increasing hemoglobin (P < 0.001) and serum ferritin (P < 0.001) concentrations from baseline values in the children with or without infection. There was no significant improvement in iron status in the children who received placebo. In both the infection group and the control group, the mean number of URTI episodes and the total number of days sick with an URTI during the period of intervention were significantly lower (P < 0.005 and P < 0.001, respectively) in the children who received iron supplements than in those who received placebo. CONCLUSION: Iron supplementation significantly improves iron status and reduces morbidity from URTIs in children with or without infection.



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