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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
JoAnn E. Manson, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00000541
First received: October 27, 1999
Last updated: August 4, 2014
Last verified: August 2014

October 27, 1999
August 4, 2014
May 1993
July 2005   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00000541 on ClinicalTrials.gov Archive Site
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Women's Antioxidant and Folic Acid Cardiovascular Study (WAFACS)
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.

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Factorial Assignment
Primary Purpose: Prevention
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
July 2005
July 2005   (final data collection date for primary outcome measure)

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

Female
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00000541
84, R01HL046959
Yes
JoAnn E. Manson, MD, Brigham and Women's Hospital
Brigham and Women's Hospital
National Heart, Lung, and Blood Institute (NHLBI)
Investigator: JoAnn Manson Brigham and Women's Hospital
Brigham and Women's Hospital
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP