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NCT Number: NCT00000541

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

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.

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Key information

Conditions

Cardiovascular Diseases Arterial Occlusive Diseases Arteriosclerosis Coronary Arteriosclerosis Coronary Artery Disease Coronary Disease Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

40 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Women, aged 40 and over, at high risk, with a history of cardiovascular disease or three or more coronary heart disease risk factors.

Treatment and study plan

dietary supplements

Behavioral

Vitamin C

Drug

Vitamin E

Drug

beta-carotene

Drug

folic acid/Vitamin B6/Vitamin B12

Drug

Primary outcomes

  1. Cardiovascular disease

  2. Cancer

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Acronym: WAFACS

Important dates

Study start
1993
Primary completion
2005
Study completion
2005
First posted
Oct 28, 1999
Registry last updated
Jul 15, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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