Trial record 1 of 1 for:    NCT00000541
Previous Study | Return to List | Next Study

Women's Antioxidant and Cardiovascular Study (WACS)

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00000541
First received: October 27, 1999
Last updated: January 15, 2008
Last verified: January 2008

October 27, 1999
January 15, 2008
May 1993
February 2006   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00000541 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Women's Antioxidant and Cardiovascular Study (WACS)
Not Provided

To determine if supplements of vitamin C, vitamin E, beta-carotene, and B-vitamins (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.

BACKGROUND:

The antioxidant properties of vitamin C, vitamin E, and beta-carotene are well known and are postulated to prevent lipoprotein oxidation and thereby prevent or retard atherogenesis. Folic acid, vitamin B6, vitamin B12 are involved in homocysteine metabolism and are also postulated to have cardioprotective effects. Based on the successful experience with the Physicians' Health Study, the results of a pilot study conducted in nurses, and long-term experience following a large cohort of United States nurses, the study should provide either definitive positive or informative null results regarding the study hypotheses.

DESIGN NARRATIVE:

Subjects were randomized in a 2 x 2 x 2 factorial design to 500 mg of vitamin C or placebo daily, 600 mg of vitamin E or placebo on alternate days and/or 50 mg of beta-carotene or placebo on alternate days. There was a three month run-in phase in which eligible patients received placebo caplets. Subjects were randomized only if they reported good compliance, willingness to continue in the trial, had no history of cancer, active liver disease, or use of coumadin, and expressed continued willingness to forego the use of beta-carotene and vitamin A, C, or E supplements. In 1998, participants were further randomized to the B-vitamin intervention (folic acid, vitamin B6, vitamin B12).

Baseline dietary assessments were made using food frequency questionnaires and information was obtained on aspirin and postmenopausal hormone use at entry and during followup. Subjects were randomized with a stratification by age into eight five-year increments, one being 75+. Endpoints are followed by mail and include all major cardiovascular events such as non-fatal myocardial infarction, non-fatal stroke, coronary revascularization procedures, and cardiovascular mortality. The trial is conducted as a companion to the Women's Health Study (WHS), a large randomized trial assessing the efficacy of low-dose aspirin and vitamin E in the primary prevention of cardiovascular disease and cancer among apparently healthy women.

The trial is currently in treatment and follow-up which will continue until February 2006.

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
February 2006
February 2006   (final data collection date for primary outcome measure)

Women, aged 40 and over, at high risk, with a history of coronary artery disease, carotid endarterectomy, peripheral artery surgery, 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
Not Provided
Not Provided
National Heart, Lung, and Blood Institute (NHLBI)
Not Provided
Investigator: JoAnn Manson Brigham and Women's Hospital
National Heart, Lung, and Blood Institute (NHLBI)
January 2008

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