The Norwegian Vitamin Trial (NORVIT)

University of Tromso (UiT)

Status: Completed

Conditions: Acute Myocardial Infarction

Treatments: Drug: Vitamin B12; Drug: Vitamin B6; Drug: Folic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT00266487

NRC 112812/320

NRC 138859/320

Details and patient eligibility

About

The purpose of this study is to examine whether the lowering of blood homocysteine levels by treatment with B vitamins can prevent cardiovascular disease

Full description

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.

Sex: All

Ages: 30 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind