The Norwegian Vitamin Trial (NORVIT)
The Norwegian Vitamin Trial (NORVIT)
The purpose of this study is to examine whether the lowering of blood homocysteine levels by
 treatment with B vitamins can prevent cardiovascular disease
Observational studies have demonstrated that elevated levels of plasma total homocysteine is
 a risk factor for cardiovascular disease. The purpose of this trial is to evaluate the
 efficacy of homocysteine lowering treatment with B vitamins for secondary prevention in
 patients who have experienced an acute myocardial infarction.

 This controlled, double-blind, multi-centre trial will include 3750 men and women aged 30-85
 who have experienced an acute myocardial infarction within 7 days prior to randomization.
 Participants will be randomized, in a two-by-two factorial design, to receive one of the
 following four treatments: A, folic acid 0.8 mg plus vitamin B12 0.4 mg and vitamin B6 40 mg
 per day; B, folic acid 0.8 mg plus vitamin B12 0.4 mg per day; C, vitamin B6 40 mg per day;
 D, placebo.

 The primary end point during 3.5 years of follow-up is a composite of recurrent myocardial
 infarction and stroke and sudden death attributed to coronary artery disease.
Inclusion Criteria:

 -  Acute myocardial infarction within 7 days prior to randomization

 -  Men and women aged 30-85 years

 -  Written informed consent

 Exclusion Criteria:

 -  Coexisting disease that shortens expected survival to less than 4 years

 -  Ongoing treatment with B vitamins

 -  Expected poor compliance