WAFACS, 2008 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

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 sizes	2721 / 2721
Inclusion criteria	40 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 criteria	history 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
PeriodeInclusion	jun 1995 - oct 1996
Hypothese	Superiority

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

WAFACS, 2008 trial summary PDF trial summary