Women's Antioxidant and Folic Acid Cardiovascular Study (WAFACS)
NCT ID: NCT00000541
Last Updated: 2020-07-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
INTERVENTIONAL
1993-05-31
2005-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
Interventions
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dietary supplements
vitamin C
vitamin E
beta-carotene
folic acid/Vitamin B6/Vitamin B12
Eligibility Criteria
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Inclusion Criteria
40 Years
FEMALE
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Brigham and Women's Hospital
OTHER
Responsible Party
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JoAnn E. Manson, MD
Chief, Division of Preventive Medicine, Brigham and Women's Hospital; Professor of Medicine and the Michael and Lee Bell Professor of Women's Health, Harvard Medical School
Principal Investigators
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JoAnn Manson
Role:
Brigham and Women's Hospital
References
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Manson JE, Gaziano JM, Spelsberg A, Ridker PM, Cook NR, Buring JE, Willett WC, Hennekens CH. A secondary prevention trial of antioxidant vitamins and cardiovascular disease in women. Rationale, design, and methods. The WACS Research Group. Ann Epidemiol. 1995 Jul;5(4):261-9. doi: 10.1016/1047-2797(94)00091-7.
Mason PJ, Manson JE, Sesso HD, Albert CM, Chown MJ, Cook NR, Greenland P, Ridker PM, Glynn RJ. Blood pressure and risk of secondary cardiovascular events in women: the Women's Antioxidant Cardiovascular Study (WACS). Circulation. 2004 Apr 6;109(13):1623-9. doi: 10.1161/01.CIR.0000124488.06377.77. Epub 2004 Mar 15.
Bassuk SS, Albert CM, Cook NR, Zaharris E, MacFadyen JG, Danielson E, Van Denburgh M, Buring JE, Manson JE. The Women's Antioxidant Cardiovascular Study: design and baseline characteristics of participants. J Womens Health (Larchmt). 2004 Jan-Feb;13(1):99-117. doi: 10.1089/154099904322836519.
Cook NR, Albert CM, Gaziano JM, Zaharris E, MacFadyen J, Danielson E, Buring JE, Manson JE. A randomized factorial trial of vitamins C and E and beta carotene in the secondary prevention of cardiovascular events in women: results from the Women's Antioxidant Cardiovascular Study. Arch Intern Med. 2007 Aug 13-27;167(15):1610-8. doi: 10.1001/archinte.167.15.1610.
Zhang SM, Cook NR, Albert CM, Gaziano JM, Buring JE, Manson JE. Effect of combined folic acid, vitamin B6, and vitamin B12 on cancer risk in women: a randomized trial. JAMA. 2008 Nov 5;300(17):2012-21. doi: 10.1001/jama.2008.555.
Kang JH, Cook N, Manson J, Buring JE, Albert CM, Grodstein F. A trial of B vitamins and cognitive function among women at high risk of cardiovascular disease. Am J Clin Nutr. 2008 Dec;88(6):1602-10. doi: 10.3945/ajcn.2008.26404.
Albert CM, Cook NR, Gaziano JM, Zaharris E, MacFadyen J, Danielson E, Buring JE, Manson JE. Effect of folic acid and B vitamins on risk of cardiovascular events and total mortality among women at high risk for cardiovascular disease: a randomized trial. JAMA. 2008 May 7;299(17):2027-36. doi: 10.1001/jama.299.17.2027.
Song Y, Cook NR, Albert CM, Van Denburgh M, Manson JE. Effects of vitamins C and E and beta-carotene on the risk of type 2 diabetes in women at high risk of cardiovascular disease: a randomized controlled trial. Am J Clin Nutr. 2009 Aug;90(2):429-37. doi: 10.3945/ajcn.2009.27491. Epub 2009 Jun 2.
Song Y, Cook NR, Albert CM, Van Denburgh M, Manson JE. Effect of homocysteine-lowering treatment with folic Acid and B vitamins on risk of type 2 diabetes in women: a randomized, controlled trial. Diabetes. 2009 Aug;58(8):1921-8. doi: 10.2337/db09-0087. Epub 2009 Jun 2.
Lin J, Cook NR, Albert C, Zaharris E, Gaziano JM, Van Denburgh M, Buring JE, Manson JE. Vitamins C and E and beta carotene supplementation and cancer risk: a randomized controlled trial. J Natl Cancer Inst. 2009 Jan 7;101(1):14-23. doi: 10.1093/jnci/djn438. Epub 2008 Dec 30.
Kang JH, Cook NR, Manson JE, Buring JE, Albert CM, Grodstein F. Vitamin E, vitamin C, beta carotene, and cognitive function among women with or at risk of cardiovascular disease: The Women's Antioxidant and Cardiovascular Study. Circulation. 2009 Jun 2;119(21):2772-80. doi: 10.1161/CIRCULATIONAHA.108.816900. Epub 2009 May 18.
Christen WG, Glynn RJ, Chew EY, Albert CM, Manson JE. Folic acid, pyridoxine, and cyanocobalamin combination treatment and age-related macular degeneration in women: the Women's Antioxidant and Folic Acid Cardiovascular Study. Arch Intern Med. 2009 Feb 23;169(4):335-41. doi: 10.1001/archinternmed.2008.574.
Song Y, Manson JE, Lee IM, Cook NR, Paul L, Selhub J, Giovannucci E, Zhang SM. Effect of combined folic acid, vitamin B(6), and vitamin B(12) on colorectal adenoma. J Natl Cancer Inst. 2012 Oct 17;104(20):1562-75. doi: 10.1093/jnci/djs370. Epub 2012 Oct 12.
Aday AW, Duran EK, Van Denburgh M, Kim E, Christen WG, Manson JE, Ridker PM, Pradhan AD. Homocysteine Is Associated With Future Venous Thromboembolism in 2 Prospective Cohorts of Women. Arterioscler Thromb Vasc Biol. 2021 Jul;41(7):2215-2224. doi: 10.1161/ATVBAHA.121.316397. Epub 2021 May 27.
Christen WG, Cook NR, Van Denburgh M, Zaharris E, Albert CM, Manson JE. Effect of Combined Treatment With Folic Acid, Vitamin B6, and Vitamin B12 on Plasma Biomarkers of Inflammation and Endothelial Dysfunction in Women. J Am Heart Assoc. 2018 May 18;7(11):e008517. doi: 10.1161/JAHA.117.008517.
Other Identifiers
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84
Identifier Type: -
Identifier Source: org_study_id
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