NCT00266487

The Norwegian Vitamin Trial (NORVIT)

Randomized Trial of Homocysteine-lowering With B Vitamins for Secondary Prevention of Cardiovascular Disease After Acute Myocardial Infarction. The Norwegian Vitamin Trial (NORVIT)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,750 (planned)
• Sponsor: University of Tromso · Academic / Other
• Sex: All
• Age: 30 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Acute Myocardial Infarction

Interventions

Type	Name	Description
DRUG	Folic acid
DRUG	Vitamin B12
DRUG	Vitamin B6

Timeline

• Start date: 1998-12-01
• Completion: 2004-03-01
• First posted: 2005-12-16
• Last updated: 2017-05-08

Locations

1 site across 1 country: Norway