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The Norwegian Vitamin Trial (NORVIT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00266487
First Posted: December 16, 2005
Last Update Posted: May 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
  Purpose
The purpose of this study is to examine whether the lowering of blood homocysteine levels by treatment with B vitamins can prevent cardiovascular disease

Condition Intervention
Acute Myocardial Infarction Drug: Folic acid Drug: Vitamin B12 Drug: Vitamin B6

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Randomized Trial of Homocysteine-lowering With B Vitamins for Secondary Prevention of Cardiovascular Disease After Acute Myocardial Infarction. The Norwegian Vitamin Trial (NORVIT)

Resource links provided by NLM:


Further study details as provided by University of Tromso:

Primary Outcome Measures:
  • 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:
  • 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

Estimated Enrollment: 3750
Study Start Date: December 1998
Estimated Study Completion Date: March 2004
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00266487


Locations
Norway
Institute of Community Medicine, University of Tromsø
Tromsø, Norway, N-9037
Sponsors and Collaborators
University of Tromso
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
Principal Investigator: Kaare H Bonaa, M.D., Ph.D Institute of Community Medicine, University of Tromsø, Norway
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00266487     History of Changes
Other Study ID Numbers: NRC 112812/320
NRC 138859/320
First Submitted: December 15, 2005
First Posted: December 16, 2005
Last Update Posted: May 8, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by University of Tromso:
Homocysteine
B vitamins
Folic acid
Randomized trial
Secondary prevention

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Vitamins
Folic Acid
Vitamin B 12
Hydroxocobalamin
Vitamin B 6
Pyridoxal
Pyridoxine
Vitamin B Complex
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hematinics