Acute Myocardial InfarctionNCT00266487
The Norwegian Vitamin Trial (NORVIT)
A study testing Folic acid, Vitamin B12 and Vitamin B6 in people with Acute Myocardial Infarction, run by University of Tromso at 1 site in Norway.
Trial 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 Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- Folic acid, Vitamin B12 and Vitamin B6
- How many people
- 3,750 participants
- Where
- 1 siteNorway
- Study dates
- Dec 1998to Mar 2004
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute myocardial infarction within 7 days prior to randomization
- Men and women aged 30-85 years
- Written informed consent
Who cannot join
- Coexisting disease that shortens expected survival to less than 4 years
- Ongoing treatment with B vitamins
- Expected poor compliance
Trial locations and contacts
1 site in 1 country.
Norway1 site
Institute of Community Medicine, University of Tromsø
Tromsø, N-9037
About this study
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)
The purpose of this study is to examine whether the lowering of blood homocysteine levels by treatment with B vitamins can prevent cardiovascular disease
Read the 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.
- Conditions
- Acute Myocardial Infarction
- Being tested
- Folic acid, Vitamin B12, Vitamin B6
- Keywords
- Homocysteine, B vitamins, Folic acid, Randomized trial, Secondary prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Folic acidDrug
Vitamin B12Drug
Vitamin B6Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2005 (estimated)
- Study startDec 1998
- Study completionMar 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Enrolment
- 3,750 participants
Sponsor and investigators
- Lead sponsor
- University of Tromso
- Sponsor type
- University, hospital or other
- 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
- Kaare H Bonaa, M.D., Ph.D, Principal investigator, Institute of Community Medicine, University of Tromsø, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00266487
- Sponsor's protocol ID
- NRC 112812/320
- Other IDs
- NRC 138859/320
- Status last verified
- May 2017
- First submitted
- 15 Dec 2005
- Last updated
- 8 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 16531614Dhar 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.
PubMed 31005968
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00266487
- Acronym / sponsor ID
- NRC 112812/320
- Conditions
- Acute Myocardial Infarction
- Keywords
- Homocysteine, B vitamins, Folic acid, Randomized trial, Secondary prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,750 participants
- Lead sponsor
- University of TromsoUniversity, hospital or other
- 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
- Study start
- Dec 1998
- Study completion
- Mar 2004
- First posted
- 16 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Acute myocardial infarction within 7 days prior to randomization
- Men and women aged 30-85 years
- Written informed consent
Key exclusion criteria (3 listed)
- Coexisting disease that shortens expected survival to less than 4 years
- Ongoing treatment with B vitamins
- Expected poor compliance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Folic acid | Drug | – |
| Vitamin B12 | Drug | – |
| Vitamin B6 | Drug | – |
Primary outcome
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.
16 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2017.
- Results publication: PubMed 16531614Bonaa 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.
- Derived from this study: PubMed 31005968Dhar 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kaare H Bonaa, M.D., Ph.D principal investigator
Institute of Community Medicine, University of Tromsø, Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Folic acid, Vitamin B12 and Vitamin B6 in people with Acute Myocardial Infarction, run by University of Tromso at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary end point was a composite of. The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00266487, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2017.