Trial record 1 of 1 for:
NCT00000541
Women's Antioxidant and Folic Acid Cardiovascular Study (WAFACS) (WAFACS)
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| ClinicalTrials.gov Identifier: NCT00000541 |
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Recruitment Status :
Completed
First Posted : October 28, 1999
Last Update Posted : July 15, 2020
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Sponsor:
Brigham and Women's Hospital
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
JoAnn E. Manson, MD, Brigham and Women's Hospital
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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 |
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.
| 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 :
- Cardiovascular disease
- 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 |
Criteria
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)
Investigators
| 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):
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 Arteriosclerosis Infarction Ischemia Pathologic Processes Necrosis Vascular Diseases Arterial Occlusive Diseases Vitamins Folic Acid |
Vitamin E Vitamin B 12 Hydroxocobalamin Vitamin B 6 Pyridoxal Pyridoxine Beta Carotene Vitamin B Complex Carotenoids Micronutrients Physiological Effects of Drugs Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Hematinics |