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The Norwegian Vitamin Trial (NORVIT)

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.
 
ClinicalTrials.gov Identifier: NCT00266487
Recruitment Status : Completed
First Posted : December 16, 2005
Last Update Posted : May 8, 2017
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

Tracking Information
First Submitted Date  ICMJE December 15, 2005
First Posted Date  ICMJE December 16, 2005
Last Update Posted Date May 8, 2017
Study Start Date  ICMJE December 1998
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: December 15, 2005)
  • 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
Current Secondary Outcome Measures  ICMJE
 (submitted: December 15, 2005)
  • 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 Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE Not Applicable
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  ICMJE Not Provided
Publications *

*   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
 (submitted: December 15, 2005)
3750
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE 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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
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  ICMJE
Plan to Share IPD: No
Current Responsible Party Not Provided
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Tromso
Original Study Sponsor  ICMJE Same as current
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