The women's antioxidant cardiovascular study: Design and baseline characteristics of participants

Background: The evidence for a potential benefit of antioxidant vitamins and folic acid in cardiovascular. disease (CVD) prevention is derived from laboratory, clinical, and observational epidemiological studies but remains inconclusive. Large-scale randomized trials with clinical end points are necessary to minimize confounding and provide unbiased estimates of the balance of benefits and risks, yet data from such trials are scarce, especially among women. Methods: The Women's Antioxidant Cardiovascular Study (WACS) is a randomized, double-blind, placebo-controlled trial testing whether antioxidant vitamins. and a folic acid/vitamin B-6/vitamin B-12 combination prevent future cardiovascular events among women I with preexisting CVD or :3 CVD risk factors. This paper describes the design of. the trial and baseline characteristics of participants, evaluates the success of randomization, and addresses the generalizabilty of future findings. Results: In a factorial design, 8171 U.S. female health professionals aged greater than or equal to40 years were randomized to vitamin E, vitamin C, beta-carotene, or placebos. Of these women, 5442 were also subsequently:randomized to folic acid/vitamin B-6/vitamin B-12 or placebo. The randomization was successful, as evidenced by similar distributions of baseline demographic, health, and behavioral characteristics across treatment groups. The clinical profile of participants was similar to that observed in another large trial of women with CVD. Conclusions: The similar distribution of known potential confounders, across treatment groups provides reassurance that unmeasured', or unknown potential confounders are also equally distributed. Although a definitive conclusion regarding generalizability requires additional trials, in diverse populations,. there is little biological. basis for supposing that the benefit-risk balance differs in other high-risk women.