"THE SU.VI.MAX STUDY": A primary prevention trial using nutritional doses of antioxidant vitamins and minerals in cardiovascular diseases and cancers

The "SUpplementation en VItamines et Miniraux AntioXydants" (SU.VI.MAX) Stu dy is a randomized double-blind, placebo-controlled, primary-prevention tri al which started in 1994 in France. This epidemiologic study is designed to test the efficacy of a daily supplementation with antioxidant vitamins (vi tamin C, 120 mg, vitamin E, 30 mg, and beta-carotene, 6 mg) and minerals (s elenium, 100 mu g, and zinc; 20 mg) at nutritional doses, in reducing the m ain causes of premature death (cancers and cardiovascular diseases); 12,735 eligible subjects (women aged 35 to 60 years, and men aged 45 to 60 years) were included in 1994 and and will be followed up for 8 years. Participant s undergo a yearly visit consisting, every other year, of either biological sampling or clinical examination. They also regularly provide information on health events and dietary intake by filling out computerized questionnai res using the Minitel Telematic Network. After 2 years of supplementation, biochemical indicators of vitamin and trace element status reach reasonable level without reaching concentrations as high as those observed in interve ntion studies, which tested relatively high doses of antioxidants, and ende d up with higher risk of pathology. (C) 1999 Published bl Elsevier Science Ltd. All rights reserved.