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
  Purpose

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.


Condition Intervention Phase
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
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: May 1993
Study Completion Date: February 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000541

Sponsors and Collaborators
Investigators
Investigator: JoAnn Manson Brigham and Women's Hospital
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00000541     History of Changes
Other Study ID Numbers: 84
Study First Received: October 27, 1999
Last Updated: January 15, 2008
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Arteriosclerosis
Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Infarction
Ischemia
Myocardial Infarction
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes
Necrosis
Ascorbic Acid
Vitamin E
Folic Acid
Vitamin B 12
Hydroxocobalamin
Vitamin B 6
Vitamins
Beta Carotene
Vitamin B Complex
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances
Hematinics

ClinicalTrials.gov processed this record on April 15, 2014