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Completed

NCT Number: NCT00266487

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

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Key information

Conditions

Acute Myocardial Infarction

Age range

30 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Community Medicine, University of Tromsø

Tromsø, N-9037, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Folic Acid

Drug

Vitamin B12

Drug

Vitamin B6

Drug

Primary outcomes

  1. The primary end point was a composite of

  2. nonfatal myocardial infarction,

  3. fatal myocardial infarction,

  4. nonfatal stroke,

  5. fatal stroke, and

  6. sudden death attributed to coronary heart disease.

Secondary outcomes

  1. Individual components of the primary end point, i.e.

  2. Nonfatal myocardial infarction

  3. Fatal myocardial infarction

  4. Nonfatal stroke

  5. Fatal stroke

  6. In addition the following secondary outcomes:

  7. Unstable angina pectoris requiring hospitalization

  8. Percutaneous coronary revascularization

  9. Coronary-artery bypass grafting

  10. Death from any cause

  11. Cancer

  12. Pulmonary embolus

  13. Transitoric ischemic attack

  14. Surgery for abdominal aortic aneurysm

  15. Plasma homocysteine levels

  16. Plasma levels of B vitamins

Sponsors and collaborators

Lead sponsor

University of Tromso

Other

Collaborators

  • Foundation to Promote Research into Functional Vitamin B12 Deficiency, Bergen, Norway
  • The Council on Health and Rehabilitation, Norway
  • The International Federation of Red Cross and Red Crescent Societies
  • The Norwegian Council on Cardiovascular Disease
  • The Research Council of Norway
  • The Royal Norwegian Ministry of Health

Registry information

Official study title

Randomized Trial of Homocysteine-lowering With B Vitamins for Secondary Prevention of Cardiovascular Disease After Acute Myocardial Infarction. The Norwegian Vitamin Trial (NORVIT)

Important dates

Study start
1998
Study completion
2004
First posted
Dec 16, 2005
Registry last updated
May 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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