The application proposes to extend the follow-up of the Women's Anti- oxidant Cardiovascular Study for four years. In addition, all subjects who are willing to participate will be randomized again to receive a combination of folate/B12/B6 or placebo. The clinical trial is currently funded. However, due to problems with recruitment and packaging of drugs, the mean follow-up of participants will be 21 months instead of the 48 months anticipated at the inception of the grant. The current support is requested in order to have adequate power to assess the effects of Vit E, Beta-carotene, the combination of Vit C, B12/folate, B6 versus placebo on a combined endpoint of CV morbidity and mortality in 8,160 at high risk for previous MI or three risk factors for CAD.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Research Project (R01)
Project #
5R01HL046959-09
Application #
6389180
Study Section
Clinical Trials Review Committee (CLTR)
Program Officer
Schron, Eleanor
Project Start
1993-05-01
Project End
2002-08-31
Budget Start
2001-09-01
Budget End
2002-08-31
Support Year
9
Fiscal Year
2001
Total Cost
$571,758
Indirect Cost
Name
Brigham and Women's Hospital
Department
Type
DUNS #
071723621
City
Boston
State
MA
Country
United States
Zip Code
02115
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