The Norwegian Vitamin Trial (NORVIT)

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	Complete list of historical versions of study NCT00266487 on ClinicalTrials.gov Archive Site
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 Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	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	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	Not Provided
Publications *	Bønaa KH, Njølstad 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. Epub 2006 Mar 12.
* 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	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	Sexes Eligible for Study: All
Ages	30 Years to 85 Years (Adult, Senior)
Accepts Healthy Volunteers	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	Plan to Share IPD: No
Responsible Party	Not Provided
Study Sponsor ICMJE	University of Tromso
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