Women's Antioxidant and Folic Acid Cardiovascular Study (WAFACS) (WAFACS)

This study has been completed.
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
JoAnn E. Manson, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
First received: October 27, 1999
Last updated: January 7, 2016
Last verified: January 2016
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 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.

Ages Eligible for Study:   40 Years and older
Genders 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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00000541

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


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 
Study First Received: October 27, 1999
Last Updated: January 7, 2016
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cardiovascular Diseases
Coronary Artery Disease
Coronary Disease
Myocardial Infarction
Myocardial Ischemia
Arterial Occlusive Diseases
Heart Diseases
Vascular Diseases
Beta Carotene
Folic Acid
Vitamin B 12
Vitamin B Complex
Growth Substances
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Protective Agents

ClinicalTrials.gov processed this record on May 26, 2016