The Norwegian Vitamin Trial (NORVIT)
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ClinicalTrials.gov Identifier: NCT00266487 |
Recruitment Status :
Completed
First Posted : December 16, 2005
Last Update Posted : May 8, 2017
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Tracking Information | |||||
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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 |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | 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. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Factorial Assignment Masking: Double Primary Purpose: Treatment |
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Condition ICMJE | Acute Myocardial Infarction | ||||
Intervention ICMJE |
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Study Arms ICMJE | Not Provided | ||||
Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE |
3750 | ||||
Original Enrollment ICMJE | Same as current | ||||
Study Completion Date ICMJE | March 2004 | ||||
Primary Completion Date | Not Provided | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 30 Years to 85 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | 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 |
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Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Not Provided | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | University of Tromso | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE |
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Investigators ICMJE |
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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 |