NCT00000541

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: Female
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Cardiovascular Diseases
• Coronary Arteriosclerosis
• Coronary Disease
• Heart Diseases
• Myocardial Infarction
• Myocardial Ischemia

Interventions

Type	Name	Description
BEHAVIORAL	dietary supplements
DRUG	vitamin C
DRUG	vitamin E
DRUG	beta-carotene
DRUG	folic acid/Vitamin B6/Vitamin B12

Timeline

• Start date: 1993-05-01
• Primary completion: 2005-07-01
• Completion: 2005-07-01
• First posted: 1999-10-28
• Last updated: 2020-07-15