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 #
2R01HL046959-06
Application #
2387364
Study Section
Clinical Trials Review Committee (CLTR)
Project Start
1993-05-01
Project End
2002-08-31
Budget Start
1998-09-30
Budget End
1999-08-31
Support Year
6
Fiscal Year
1998
Total Cost
Indirect Cost
Name
Brigham and Women's Hospital
Department
Type
DUNS #
071723621
City
Boston
State
MA
Country
United States
Zip Code
02115
Ashar, Foram N; Mitchell, Rebecca N; Albert, Christine M et al. (2018) A comprehensive evaluation of the genetic architecture of sudden cardiac arrest. Eur Heart J 39:3961-3969
Stone, Katie L; Lui, Li-Yung; Christen, William G et al. (2017) Effect of Combination Folic Acid, Vitamin B6 , and Vitamin B12 Supplementation on Fracture Risk in Women: A Randomized, Controlled Trial. J Bone Miner Res 32:2331-2338
Patel, Ravi B; Moorthy, M V; Chiuve, Stephanie E et al. (2017) Hemoglobin A1c levels and risk of sudden cardiac death: A nested case-control study. Heart Rhythm 14:72-78
Christen, William G; Glynn, Robert J; Chew, Emily Y et al. (2016) Folic Acid, Vitamin B6, and Vitamin B12 in Combination and Age-Related Cataract in a Randomized Trial of Women. Ophthalmic Epidemiol 23:32-9
Okereke, Olivia I; Cook, Nancy R; Albert, Christine M et al. (2015) Effect of long-term supplementation with folic acid and B vitamins on risk of depression in older women. Br J Psychiatry 206:324-31
Lemaitre, Rozenn N; Johnson, Catherine O; Hesselson, Stephanie et al. (2014) Common variation in fatty acid metabolic genes and risk of incident sudden cardiac arrest. Heart Rhythm 11:471-7
Schaumberg, Debra A; Rose, Lynda; DeAngelis, Margaret M et al. (2014) Prospective study of common variants in CX3CR1 and risk of macular degeneration: pooled analysis from 5 long-term studies. JAMA Ophthalmol 132:84-95
Huertas-Vazquez, Adriana; Teodorescu, Carmen; Reinier, Kyndaron et al. (2013) A common missense variant in the neuregulin 1 gene is associated with both schizophrenia and sudden cardiac death. Heart Rhythm 10:994-8
Vercambre, Marie-Noel; Berr, Claudine; Ritchie, Karen et al. (2013) Caffeine and cognitive decline in elderly women at high vascular risk. J Alzheimers Dis 35:413-21
Mitta, Vinod P; Christen, William G; Glynn, Robert J et al. (2013) C-reactive protein and the incidence of macular degeneration: pooled analysis of 5 cohorts. JAMA Ophthalmol 131:507-13

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