WAFACS, 2008 trial summary    PDF trial summary

A randomised clinical trial investigating the effect of folic acid, vit B12 and vit B6 versus placebo in women aged 42 years or older, with either a history of CVD or 3 or more coronary risk factors

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NCT00000541    Diabetes 2009;58:1921-8  



Studied treatment folic acid 2.5mg, vitamin B6 50mg, and vitamin B12 1mg daily
Control treatment placebo
Age (yr) 62.8 y
Male sex 0%



Patients women aged 42 years or older, with either a history of CVD or 3 or more coronary risk factors
Group sizes2721 / 2721
Inclusion criteria40 years or older, postmenopausal or had no intention of becoming pregnant, and had a reported history of CVD or had at least 3 cardiac risk factors;
Exclusion criteriahistory of cancer (excluding nonmelanoma skin cancer) within the past 10 years, any serious non-CVD illness, or were currently using warfarin or other anticoagulants
nephropathy
BMI NA
diabetes (%) 21%



Blindness double blind Inclusion period jun 1995 - oct 1996
Follow-up duration 7.3 y Centers
Lost to FU geographical localisation US
Primary endpoint cardiovascular events Design Parallel groups
PeriodeInclusionjun 1995 - oct 1996
HypotheseSuperiority



EndpointX1N1X0N0TE95% CI Death from any cause 250 2721 256 2721 0,98[0,81; 1,17] stroke (fatal & non fatal) 79 2721 69 2721 1,14[0,83; 1,59] Death due to cancer - 2721 - 2721 no data Death from cardiovascular causes 96 2721 94 2721 1,02[0,76; 1,36] cardiovascular event (fatal and non fatal) 406 2721 390 2721 1,04[0,90; 1,21] Death from CHD 283 2721 280 2721 1,01[0,85; 1,20] Myocardial infarction 65 2721 74 2721 0,88[0,63; 1,23] Incident cancer - 2721 - 2721 no data Non fatal MI - 2721 - 2721 no data0,22,01,0

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;299:2027-36     [PMID: 18460663]   link to pdf   add to Mendeley  

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;58:1921-8     [PMID: 19491213]   link to pdf   add to Mendeley  

ClinicalTrial.gov record NCT00000541



Registering number NCT00000541 (see trial on clinicaltrials.gov)
Code Name