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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00000541
Acronym
WAFACS
Enrollment
Unknown
Registered
1999-10-28
Start date
1993-05-31
Completion date
2005-07-31
Last updated
2020-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

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.

Interventions

BEHAVIORALdietary supplements
DRUGvitamin C
DRUGvitamin E
DRUGfolic acid/Vitamin B6/Vitamin B12

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
Brigham and Women's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION

Eligibility

Sex/Gender
FEMALE
Age
40 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Cardiovascular disease
Cancer

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 5, 2026