The SU.VI.MAX Study: a randomized, placebo-controlled trial of the health effects of antioxidant vitamins and minerals.
What this study found
Overall, low-dose antioxidant supplementation did not significantly reduce ischemic cardiovascular disease, but it appeared beneficial for cancer and mortality in men. Ischemic cardiovascular disease incidence was 134 (2.1) versus 137 (2.1), RR 0.97 (0.77-1.20), P = .80. Overall cancer incidence was 267 (4.2) versus 295 (4.6), RR 0.90 (0.76-1.06), P = .19, with a significant sex interaction (P = .02); cancer was reduced in men, 88 (3.5) versus 124 (4.9), RR 0.69 (0.53-0.91), P = .008, but not in women, 179 (4.7) versus 171 (4.4), RR 1.04 (0.85-1.29), P = .53. All-cause mortality showed a…
- Study & population
- Randomized, placebo-controlled, intention-to-treat trial in French adults from the general population who were not selected for high cardiovascular or cancer risk.
- Intervention
- A single oral daily capsule of low-dose antioxidants and minerals: 120 mg ascorbic acid, 30 mg vitamin E, 6 mg beta carotene, 100 µg selenium as selenium-enriched yeast, and 20 mg zinc as gluconate.
- Key limitation
- The main overall outcomes were not statistically significant, so the positive findings rely largely on sex-specific subgroup analyses.
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Open PDFOriginal abstract
BACKGROUND It has been suggested that a low dietary intake of antioxidant vitamins and minerals increases the incidence rate of cardiovascular disease and cancer. To date, however, the published results of randomized, placebo-controlled trials of supplements containing antioxidant nutrients have not provided clear evidence of a beneficial effect. We tested the efficacy of nutritional doses of supplementation with a combination of antioxidant vitamins and minerals in reducing the incidence of cancer and ischemic cardiovascular disease in the general population. METHODS The Supplementation en Vitamines et Mineraux Antioxydants (SU.VI.MAX) study is a randomized, double-blind, placebo-controlled primary prevention trial. A total of 13 017 French adults (7876 women aged 35-60 years and 5141 men aged 45-60 years) were included. All participants took a single daily capsule of a combination of 120 mg of ascorbic acid, 30 mg of vitamin E, 6 mg of beta carotene, 100 mug of selenium, and 20 mg of zinc, or a placebo. Median follow-up time was 7.5 years. RESULTS No major differences were detected between the groups in total cancer incidence (267 [4.1%] for the study group vs 295 [4.5%] for the placebo group), ischemic cardiovascular disease incidence (134 [2.1%] vs 137[2.1%]), or all-cause mortality (76 [1.2%] vs 98 [1.5%]). However, a significant interaction between sex and group effects on cancer incidence was found (P = .004). Sex-stratified analysis showed a protective effect of antioxidants in men (relative risk, 0.69 [95% confidence interval [CI], 0.53-0.91]) but not in women (relative risk, 1.04 [95% CI, 0.85-1.29]). A similar trend was observed for all-cause mortality (relative risk, 0.63 [95% CI, 0.42-0.93] in men vs 1.03 [95% CI, 0.64-1.63] in women; P = .11 for interaction). CONCLUSIONS After 7.5 years, low-dose antioxidant supplementation lowered total cancer incidence and all-cause mortality in men but not in women. Supplementation may be effective in men only because of their lower baseline status of certain antioxidants, especially of beta carotene.