The Norwegian Vitamin Trial (NORVIT)

Not Applicable

Completed

• Conditions: Acute Myocardial Infarction

• Registration Number: NCT00266487
• Lead Sponsor: University of Tromso

Brief 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.

Study Timeline

• Study Start: 1998-12
• Study Completion: 2004-03
• Study First Submitted: 2005-12-15
• Study First Submitted QC: 2005-12-15
• Study First Posted: 2005-12-16
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-03
• Last Update Posted: 2017-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3750

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
The primary end point was a composite of
nonfatal stroke,
fatal myocardial infarction,
nonfatal myocardial infarction,
fatal stroke, and
sudden death attributed to coronary heart disease.

Secondary Outcome Measures

Name	Time	Method
Transitoric ischemic attack
Individual components of the primary end point, i.e.
Nonfatal myocardial infarction
Surgery for abdominal aortic aneurysm
Plasma homocysteine levels
Nonfatal stroke
Fatal stroke
Unstable angina pectoris requiring hospitalization
Cancer
Fatal myocardial infarction
Percutaneous coronary revascularization
Coronary-artery bypass grafting
Pulmonary embolus
In addition the following secondary outcomes:
Death from any cause
Plasma levels of B vitamins

Trial Locations

Locations (1)

Institute of Community Medicine, University of Tromsø; 🇳🇴 Tromsø, Norway