Viewing Study NCT00000541



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Last Modification Date: 2024-10-26 @ 9:01 AM
Study NCT ID: NCT00000541
Status: COMPLETED
Last Update Posted: 2020-07-15
First Post: 1999-10-27

Brief Title: Womens Antioxidant and Folic Acid Cardiovascular Study WAFACS
Sponsor: Brigham and Womens Hospital
Organization: Brigham and Womens Hospital

Study Overview

Official Title: Womens Antioxidant and Folic Acid Cardiovascular Study WAFACS
Status: COMPLETED
Status Verified Date: 2020-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: WAFACS
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 Womens Health Study WHS a primary prevention trial of vitamin E and aspirin in a low risk population of women
Detailed Description: The Womens Antioxidant and Folic Acid Cardiovascular Study tested the effects of vitamin C 500 mgday vitamin E 600 IU every other day andor 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 94 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 25 mg vitamin B6 50 mg vitamin B12 1 mg and were followed for 73 years from April 1998 through July 2005

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
R01HL046959 NIH None httpsreporternihgovquickSearchR01HL046959