The Norwegian Vitamin Trial (NORVIT)

• ClinicalTrials.gov Identifier: NCT00266487
• Recruitment Status: Completed
• First Posted: December 16, 2005
• Last Update Posted: May 8, 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
• Information provided by: University of Tromso

Tracking Information

• First Submitted Date: December 15, 2005
• First Posted Date: December 16, 2005
• Last Update Posted Date: May 8, 2017
• Study Start Date: December 1998
• Primary Completion Date: Not Provided

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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)
• 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Factorial Assignment; Masking: Double; Primary Purpose: Treatment
• Condition: Acute Myocardial Infarction

Intervention

• Drug: Folic acid
• Drug: Vitamin B12
• Drug: Vitamin B6

• Study Arms: Not Provided

Publications *

• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Enrollment (submitted: December 15, 2005): 3750
• Original Enrollment: Same as current
• Study Completion Date: March 2004
• Primary Completion Date: Not Provided

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 30 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Norway

Administrative Information

• NCT Number: NCT00266487
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Current Responsible Party: Not Provided
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Tromso
• Original Study Sponsor: Same as current

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

Investigators

• 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