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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, 2006
Last verified: August 2005

December 15, 2005
May 3, 2006
December 1998
Not Provided
  • 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.
Same as current
Complete list of historical versions of study NCT00266487 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
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)

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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Acute Myocardial Infarction
  • Drug: Folic acid
  • Drug: Vitamin B12
  • Drug: Vitamin B6
Not Provided
Bonaa KH, Njolstad 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.
 
Completed
3750
March 2004
Not Provided

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
Both
30 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00266487
NRC 112812/320, NRC 138859/320
Not Provided
Not Provided
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
Principal Investigator: Kaare H Bonaa, M.D., Ph.D Institute of Community Medicine, University of Tromsø, Norway
University of Tromso
August 2005

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