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Trial record 1 of 1 for:    NCT00000541
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Women's Antioxidant and Folic Acid Cardiovascular Study (WAFACS) (WAFACS)

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ClinicalTrials.gov Identifier: NCT00000541
Recruitment Status : Completed
First Posted : October 28, 1999
Last Update Posted : July 15, 2020
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
JoAnn E. Manson, MD, Brigham and Women's Hospital

Brief Summary:
To determine if supplements of vitamin C, vitamin E, beta-carotene, and B-vitamins (a combination of 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.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Coronary Arteriosclerosis Coronary Disease Heart Diseases Myocardial Infarction Myocardial Ischemia Behavioral: dietary supplements Drug: vitamin C Drug: vitamin E Drug: beta-carotene Drug: folic acid/Vitamin B6/Vitamin B12 Phase 2

Detailed Description:
The Women's Antioxidant and Folic Acid Cardiovascular Study tested the effects of vitamin C (500 mg/day), vitamin E (600 IU every other day), and/or beta carotene (50 mg every other day) on the risk of major cardiovascular events (a combined outcome of myocardial infarction, stroke, coronary revascularization, or cardiovascular death) among 8171 female health professionals at increased risk. Participants were 40 years or older with a history of cardiovascular disease or 3 or more cardiovascular risk factors and were followed for an average duration of 9.4 years, from 1995-1996 to 2005. In 1998, 5442 of these participants were further randomized to the B-vitamin intervention (a daily combination pill containing folic acid [2.5 mg], vitamin B6 [50 mg], vitamin B12 [1 mg]) and were followed for 7.3 years, from April 1998 through July 2005.

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Factorial Assignment
Primary Purpose: Prevention
Official Title: Women's Antioxidant and Folic Acid Cardiovascular Study (WAFACS)
Study Start Date : May 1993
Actual Primary Completion Date : July 2005
Actual Study Completion Date : July 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Folic acid

Primary Outcome Measures :
  1. Cardiovascular disease
  2. Cancer

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Women, aged 40 and over, at high risk, with a history of cardiovascular disease or three or more coronary heart disease risk factors.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000541

Sponsors and Collaborators
Brigham and Women's Hospital
National Heart, Lung, and Blood Institute (NHLBI)
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OverallOfficial: JoAnn Manson Brigham and Women's Hospital
Publications of Results:

Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: JoAnn E. Manson, MD, Chief, Division of Preventive Medicine, Brigham and Women's Hospital; Professor of Medicine and the Michael and Lee Bell Professor of Women's Health, Harvard Medical School, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00000541    
Other Study ID Numbers: 84
R01HL046959 ( U.S. NIH Grant/Contract )
First Posted: October 28, 1999    Key Record Dates
Last Update Posted: July 15, 2020
Last Verified: July 2020
Additional relevant MeSH terms:
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Cardiovascular Diseases
Myocardial Infarction
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Pathologic Processes
Vascular Diseases
Arterial Occlusive Diseases
Folic Acid
Vitamin E
Vitamin B 12
Vitamin B 6
Beta Carotene
Vitamin B Complex
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Protective Agents