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.
Behavioral: dietary supplements
Drug: vitamin C
Drug: vitamin E
Drug: folic acid/Vitamin B6/Vitamin B12
|Study Design:||Allocation: Randomized
Intervention Model: Factorial Assignment
Primary Purpose: Prevention
|Official Title:||Women's Antioxidant and Folic Acid Cardiovascular Study (WAFACS)|
|Study Start Date:||May 1993|
|Study Completion Date:||July 2005|
|Primary Completion Date:||July 2005 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000541
|Investigator:||JoAnn Manson||Brigham and Women's Hospital|