The Norwegian Vitamin Trial (NORVIT)

This study has been completed.

Sponsor:

Collaborators:

The Research Council of Norway

The Council on Health and Rehabilitation, Norway

The Norwegian Council on Cardiovascular Disease

The Royal Norwegian Ministry of Health

The International Federation of Red Cross and Red Crescent Societies

Foundation to Promote Research into Functional Vitamin B12 Deficiency, Bergen, Norway

Information provided by:

University of Tromso

ClinicalTrials.gov Identifier:

NCT00266487

First received: December 15, 2005

Last updated: May 3, 2017

Last verified: May 2017

History of Changes

Tracking Information

First Received Date ^ICMJE

December 15, 2005

Last Updated Date

May 3, 2017

Start Date ^ICMJE

December 1998

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00266487 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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
Cancer
Pulmonary embolus
Transitoric ischemic attack
Surgery for abdominal aortic aneurysm
Plasma homocysteine levels
Plasma levels of B vitamins

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

The Norwegian Vitamin Trial (NORVIT)

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double
Primary Purpose: Treatment

Condition ^ICMJE

Acute Myocardial Infarction

Intervention ^ICMJE

Drug: Folic acid
Drug: Vitamin B12
Drug: Vitamin B6

Study Arms

Not Provided

Publications *

Bønaa KH, Njølstad I, Ueland PM, Schirmer H, Tverdal A, Steigen T, Wang H, Nordrehaug JE, Arnesen E, Rasmussen K; NORVIT Trial Investigators. Homocysteine lowering and cardiovascular events after acute myocardial infarction. N Engl J Med. 2006 Apr 13;354(15):1578-88. Epub 2006 Mar 12.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

3750

Estimated Completion Date

March 2004

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

30 Years to 85 Years (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Norway

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00266487

Other Study ID Numbers ^ICMJE

NRC 112812/320
NRC 138859/320

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

Not Provided

Study Sponsor ^ICMJE

University of Tromso

Collaborators ^ICMJE

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

Investigators ^ICMJE

Principal Investigator:

Kaare H Bonaa, M.D., Ph.D

Institute of Community Medicine, University of Tromsø, Norway

PRS Account

University of Tromso

Verification Date

May 2017

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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