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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 : January 18, 2018
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Study Design

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
Primary Completion Date : July 2005
Study Completion Date : July 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Folic acid
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Cardiovascular disease
  2. Cancer

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
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.
Contacts and Locations

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
More Information

Publications:

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     History of Changes
Other Study ID Numbers: 84
R01HL046959 ( U.S. NIH Grant/Contract )
First Posted: October 28, 1999    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Infarction
Cardiovascular Diseases
Heart Diseases
Myocardial Infarction
Ischemia
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Arteriosclerosis
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
Antioxidants
Carotenoids
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hematinics
Molecular Mechanisms of Pharmacological Action