A PRIMARY PREVENTION TRIAL USING NUTRITIONAL DOSES OF ANTIOXIDANT VITAMINS AND MINERALS IN CARDIOVASCULAR-DISEASES AND CANCERS IN A GENERAL-POPULATION - THE SU.VI.MAX STUDY - DESIGN, METHODS, AND PARTICIPANT CHARACTERISTICS

The SUpplementation en VItamines et Mineraux AntioXydants (SU.VI.MAX) Study is a randomized, double-blind, placebo-controlled, primary-preve ntion trial designed to test the efficacy of daily supplementation wit h antioxidant vitamins (vitamin C, 120 mg; vitamin E, 30 mg; and beta- carotene, 6 mg) and minerals (selenium, 100 mu g; and zinc, 20 mg) at nutrition-level doses (one to three times the daily recommended dietar y allowances) in reducing several major health problems in industriali zed countries, especially the main causes of premature death, cancers and cardiovascular diseases. The present report describes the design, implementation, and baseline characteristics of participants in this 8 -year cohort study, which started in 1994 in France; 12,735 eligible s ubjects (women aged 35-60, and men aged 45-60) were included in 1994 a nd will be followed for 8 years. Participants undergo a yearly visit c onsisting, 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 questionnaires using th e Minitel Telematic Network. Data on baseline characteristics of the p articipants suggest that the present sample is close to the national p opulation in terms of geographic density, socioeconomic status, and th e distribution of various major risk factors for the diseases under st udy. The choice of the study population should allow the results of th is trial to apply to adult populations of both sexes in France and oth er industrialized countries. (C) Elsevier Science Inc. 1998.