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The Women's Antioxidant Cardiovascular Study: design and baseline characteristics of participants.

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Title: The Women's Antioxidant Cardiovascular Study: design and baseline characteristics of participants.
Authors: Bassuk SS (AUTHOR), Albert CM (AUTHOR), Cook NR (AUTHOR), Zaharris E (AUTHOR), MacFadyen JG (AUTHOR), Danielson E (AUTHOR), Van Denburgh M (AUTHOR), Buring JE (AUTHOR), Manson JE (AUTHOR)
Source: Journal of Women's Health (15409996). Jan/Feb2004, Vol. 13 Issue 1, p99-117. 19p.
Subjects: Vitamins, Folic acid, Antioxidants, Cardiovascular disease prevention, Nutrition
Abstract: 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 B6/vitamin B12 combination prevent future cardiovascular events among women 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 generalizability of future findings. Results: In a factorial design, 8171 U.S. female health professionals aged ≥ 40 years were randomized to vitamin E, vitamin C, beta-carotene, or placebos. Of these women, 5442 were also subsequently randomized to folic acid/vitamin B6/vitamin B12 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. [ABSTRACT FROM AUTHOR]
Copyright of Journal of Women's Health (15409996) is the property of Mary Ann Liebert, Inc. and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
Database: Psychology and Behavioral Sciences Collection
Description
Abstract: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 B6/vitamin B12 combination prevent future cardiovascular events among women 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 generalizability of future findings. Results: In a factorial design, 8171 U.S. female health professionals aged ≥ 40 years were randomized to vitamin E, vitamin C, beta-carotene, or placebos. Of these women, 5442 were also subsequently randomized to folic acid/vitamin B6/vitamin B12 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. [ABSTRACT FROM AUTHOR]
ISSN:15409996
DOI:10.1089/154099904322836519