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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)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000541
First Posted: October 28, 1999
Last Update Posted: July 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
JoAnn E. Manson, MD, Brigham and Women's Hospital
  Purpose
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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Primary Purpose: Prevention
Official Title: Women's Antioxidant and Folic Acid Cardiovascular Study (WAFACS)

Resource links provided by NLM:


Further study details as provided by JoAnn E. Manson, MD, Brigham and Women's Hospital:

Primary Outcome Measures:
  • Cardiovascular disease
  • Cancer

Study Start Date: May 1993
Study Completion Date: July 2005
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
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.
  Eligibility

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 Submitted: October 27, 1999
First Posted: October 28, 1999
Last Update Posted: July 13, 2017
Last Verified: July 2017

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