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Trial NCT00000541

Resource URI: http://static.linkedct.org/resource/trials/NCT00000541
linkedct:brief_title Women's Antioxidant and Cardiovascular Study (WACS)
linkedct:condition <http://static.linkedct.org/resource/condition/2312>
linkedct:condition <http://static.linkedct.org/resource/condition/3361>
linkedct:condition <http://static.linkedct.org/resource/condition/3388>
linkedct:condition <http://static.linkedct.org/resource/condition/5702>
linkedct:condition <http://static.linkedct.org/resource/condition/8483>
linkedct:condition <http://static.linkedct.org/resource/condition/8489>
linkedct:criteria Women, aged 40 and over, at high risk, with a history of coronary artery disease, carotid endarterectomy, peripheral artery surgery, or three or more coronary heart disease risk factors.
linkedct:description BACKGROUND: The antioxidant properties of vitamin C, vitamin E, and beta-carotene are well known and are postulated to prevent lipoprotein oxidation and thereby prevent or retard atherogenesis. Folic acid, vitamin B6, vitamin B12 are involved in homocysteine metabolism and are also postulated to have cardioprotective effects. Based on the successful experience with the Physicians' Health Study, the results of a pilot study conducted in nurses, and long-term experience following a large cohort of United States nurses, the study should provide either definitive positive or informative null results regarding the study hypotheses. DESIGN NARRATIVE: Subjects were randomized in a 2 x 2 x 2 factorial design to 500 mg of vitamin C or placebo daily, 600 mg of vitamin E or placebo on alternate days and/or 50 mg of beta-carotene or placebo on alternate days. There was a three month run-in phase in which eligible patients received placebo caplets. Subjects were randomized only if they reported good compliance, willingness to continue in the trial, had no history of cancer, active liver disease, or use of coumadin, and expressed continued willingness to forego the use of beta-carotene and vitamin A, C, or E supplements. In 1998, participants were further randomized to the B-vitamin intervention (folic acid, vitamin B6, vitamin B12). Baseline dietary assessments were made using food frequency questionnaires and information was obtained on aspirin and postmenopausal hormone use at entry and during followup. Subjects were randomized with a stratification by age into eight five-year increments, one being 75+. Endpoints are followed by mail and include all major cardiovascular events such as non-fatal myocardial infarction, non-fatal stroke, coronary revascularization procedures, and cardiovascular mortality. The trial is conducted as a companion to the Women's Health Study (WHS), a large randomized trial assessing the efficacy of low-dose aspirin and vitamin E in the primary prevention of cardiovascular disease and cancer among apparently healthy women. The trial is currently in treatment and follow-up which will continue until February 2006.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Female
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age N/A
linkedct:eligibility_minimum_age 40 Years
linkedct:end_date February 2006
linkedct:enrollment 0 (xsd:int)
linkedct:firstreceived_date October 27, 1999
linkedct:id NCT00000541
rdfs:label Trial NCT00000541
linkedct:lastchanged_date January 15, 2008
linkedct:lead_sponsor_agency National Heart, Lung, and Blood Institute (NHLBI)
linkedct:nct_id NCT00000541
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:org_study_id 84
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/28219>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000541>
linkedct:phase Phase 2
linkedct:primary_completion_date February 2006
linkedct:reference <http://static.linkedct.org/resource/reference/21369>
linkedct:reference <http://static.linkedct.org/resource/reference/21472>
linkedct:reference <http://static.linkedct.org/resource/reference/49220>
linkedct:source National Heart, Lung, and Blood Institute (NHLBI)
linkedct:start_date May 1993
linkedct:study_design Prevention, Randomized, Placebo Control, Factorial Assignment
linkedct:study_type Interventional
linkedct:summary To determine if supplements of vitamin C, vitamin E, beta-carotene, and B-vitamins (folic acid, vitamins B6 and B12) reduce risk of major cardiovascular events in high risk women with a prior history of atherosclerotic cardiovascular disease. The trial is a companion to the Women's Health Study (WHS), a primary prevention trial of vitamin E and aspirin in a low risk population of women.
rdf:type linkedct:trials
linkedct:verification_date January 2008