The Norwegian Vitamin Trial (NORVIT)
Randomized Trial of Homocysteine-lowering With B Vitamins for Secondary Prevention of Cardiovascular Disease After Acute Myocardial Infarction. The Norwegian Vitamin Trial (NORVIT)
2 other identifiers
interventional
3,750
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 1998
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 1998
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2004
CompletedFirst Submitted
Initial submission to the registry
December 15, 2005
CompletedFirst Posted
Study publicly available on registry
December 16, 2005
CompletedMay 8, 2017
May 1, 2017
December 15, 2005
May 3, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
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.
Secondary Outcomes (16)
Individual components of the primary end point, i.e.
Nonfatal myocardial infarction
Fatal myocardial infarction
Nonfatal stroke
Fatal stroke
- +11 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- Acute myocardial infarction within 7 days prior to randomization
- Men and women aged 30-85 years
- Written informed consent
You may not qualify if:
- Coexisting disease that shortens expected survival to less than 4 years
- Ongoing treatment with B vitamins
- Expected poor compliance
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Tromsolead
- The Research Council of Norwaycollaborator
- The Council on Health and Rehabilitation, Norwaycollaborator
- The Norwegian Council on Cardiovascular Diseasecollaborator
- The Royal Norwegian Ministry of Healthcollaborator
- The International Federation of Red Cross and Red Crescent Societiescollaborator
- Foundation to Promote Research into Functional Vitamin B12 Deficiency, Bergen, Norwaycollaborator
Study Sites (1)
Institute of Community Medicine, University of Tromsø
Tromsø, N-9037, Norway
Related Publications (2)
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.
PMID: 16531614RESULTDhar 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.
PMID: 31005968DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kaare H Bonaa, M.D., Ph.D
Institute of Community Medicine, University of Tromsø, Norway
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 15, 2005
First Posted
December 16, 2005
Study Start
December 1, 1998
Study Completion
March 1, 2004
Last Updated
May 8, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will not share