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
|Condition or disease||Intervention/treatment||Phase|
|Acute Myocardial Infarction||Drug: Folic acid Drug: Vitamin B12 Drug: Vitamin B6||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Enrollment :||3750 participants|
|Intervention Model:||Factorial Assignment|
|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 Start Date :||December 1998|
|Study Completion Date :||March 2004|
- 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.
- 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
- Pulmonary embolus
- Transitoric ischemic attack
- Surgery for abdominal aortic aneurysm
- Plasma homocysteine levels
- Plasma levels of B vitamins
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
|Institute of Community Medicine, University of Tromsø|
|Tromsø, Norway, N-9037|
|Principal Investigator:||Kaare H Bonaa, M.D., Ph.D||Institute of Community Medicine, University of Tromsø, Norway|