The Norwegian Vitamin Trial (NORVIT)

May 3, 2017 updated by: University of Tromso

Randomized Trial of Homocysteine-lowering With B Vitamins for Secondary Prevention of Cardiovascular Disease After Acute Myocardial Infarction. 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

3750

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Tromsø, Norway, N-9037
        • Institute of Community Medicine, University of Tromsø

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Tromso

Collaborators

The Research Council of Norway
The Royal Norwegian Ministry of Health
Foundation to Promote Research into Functional Vitamin B12 Deficiency, Bergen, Norway
The International Federation of Red Cross and Red Crescent Societies
The Council on Health and Rehabilitation, Norway
The Norwegian Council on Cardiovascular Disease

Investigators

  • Principal Investigator: Kaare H Bonaa, M.D., Ph.D, Institute of Community Medicine, University of Tromsø, Norway

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 1998

Study Completion

March 1, 2004

Study Registration Dates

First Submitted

December 15, 2005

First Submitted That Met QC Criteria

December 15, 2005

First Posted (Estimate)

December 16, 2005

Study Record Updates

Last Update Posted (Actual)

May 8, 2017

Last Update Submitted That Met QC Criteria

May 3, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NRC 112812/320
  • NRC 138859/320

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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