The Norwegian Vitamin Trial (NORVIT)
Primary Purpose
Acute Myocardial Infarction
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Folic acid
Vitamin B12
Vitamin B6
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring Homocysteine, B vitamins, Folic acid, Randomized trial, Secondary prevention
Eligibility 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
Sites / Locations
- Institute of Community Medicine, University of Tromsø
Outcomes
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
Full Information
NCT ID
NCT00266487
First Posted
December 15, 2005
Last Updated
May 3, 2017
Sponsor
University of Tromso
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
1. Study Identification
Unique Protocol Identification Number
NCT00266487
Brief Title
The Norwegian Vitamin Trial (NORVIT)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
December 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Tromso
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
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction
Keywords
Homocysteine, B vitamins, Folic acid, Randomized trial, Secondary prevention
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Double
Allocation
Randomized
Enrollment
3750 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Folic acid
Intervention Type
Drug
Intervention Name(s)
Vitamin B12
Intervention Type
Drug
Intervention Name(s)
Vitamin B6
Primary Outcome Measure Information:
Title
The primary end point was a composite of
Title
nonfatal myocardial infarction,
Title
fatal myocardial infarction,
Title
nonfatal stroke,
Title
fatal stroke, and
Title
sudden death attributed to coronary heart disease.
Secondary Outcome Measure Information:
Title
Individual components of the primary end point, i.e.
Title
Nonfatal myocardial infarction
Title
Fatal myocardial infarction
Title
Nonfatal stroke
Title
Fatal stroke
Title
In addition the following secondary outcomes:
Title
Unstable angina pectoris requiring hospitalization
Title
Percutaneous coronary revascularization
Title
Coronary-artery bypass grafting
Title
Death from any cause
Title
Cancer
Title
Pulmonary embolus
Title
Transitoric ischemic attack
Title
Surgery for abdominal aortic aneurysm
Title
Plasma homocysteine levels
Title
Plasma levels of B vitamins
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kaare H Bonaa, M.D., Ph.D
Organizational Affiliation
Institute of Community Medicine, University of Tromsø, Norway
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Community Medicine, University of Tromsø
City
Tromsø
ZIP/Postal Code
N-9037
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
16531614
Citation
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. doi: 10.1056/NEJMoa055227. Epub 2006 Mar 12.
Results Reference
result
PubMed Identifier
31005968
Citation
Dhar I, Lysne V, Svingen GFT, Ueland PM, Gregory JF, Bonaa KH, Nygard OK. Elevated plasma cystathionine is associated with increased risk of mortality among patients with suspected or established coronary heart disease. Am J Clin Nutr. 2019 Jun 1;109(6):1546-1554. doi: 10.1093/ajcn/nqy391.
Results Reference
derived
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The Norwegian Vitamin Trial (NORVIT)
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