Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
3750 participants
INTERVENTIONAL
1998-12-31
2004-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
DOUBLE
Interventions
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Folic acid
Vitamin B12
Vitamin B6
Eligibility Criteria
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Inclusion Criteria
* Men and women aged 30-85 years
* Written informed consent
Exclusion Criteria
* Ongoing treatment with B vitamins
* Expected poor compliance
30 Years
85 Years
ALL
No
Sponsors
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The Research Council of Norway
OTHER
The Council on Health and Rehabilitation, Norway
UNKNOWN
The Norwegian Council on Cardiovascular Disease
UNKNOWN
The Royal Norwegian Ministry of Health
OTHER
The International Federation of Red Cross and Red Crescent Societies
OTHER
Foundation to Promote Research into Functional Vitamin B12 Deficiency, Bergen, Norway
OTHER
University of Tromso
OTHER
Principal Investigators
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Kaare H Bonaa, M.D., Ph.D
Role: PRINCIPAL_INVESTIGATOR
Institute of Community Medicine, University of Tromsø, Norway
Locations
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Institute of Community Medicine, University of Tromsø
Tromsø, , Norway
Countries
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References
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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.
Other Identifiers
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NRC 138859/320
Identifier Type: -
Identifier Source: secondary_id
NRC 112812/320
Identifier Type: -
Identifier Source: org_study_id
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