The Norwegian Vitamin Trial (NORVIT) | NCT00266487

Studies
The Norwegian Vitamin Trial (NORVIT)

NCT00266487

Sponsor

University of Tromso

Status

Completed

Last Update Posted

May 8, 2017Actual

Enrollment

3,750

Phase

Not Applicable

Conditions

Acute Myocardial Infarction

Interventions

Folic acid
Vitamin B12
Vitamin B6

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
NRC 138859/320

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1998

Primary Completion Date

Not provided

Completion Date

Mar 2004

First Submitted Date

Dec 15, 2005

First Submission Date that Met QC Criteria

Dec 15, 2005

First Posted Date

Dec 16, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 3, 2017

Last Update Posted Date

May 8, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

University of TromsoOTHER

Collaborators

Name	Class
The Research Council of Norway	OTHER
The Council on Health and Rehabilitation, Norway	UNKNOWN
The Norwegian Council on Cardiovascular Disease	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

3,750

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Individual components of the primary end point, i.e.
Nonfatal myocardial infarction
Fatal myocardial infarction

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kaare H Bonaa, M.D., Ph.D	Institute of Community Medicine, University of Tromsø, Norway	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institute of Community Medicine, University of Tromsø		Tromsø		N-9037	Norway

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16531614	Result	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.
31005968	Derived

ID	Term
D005492	Folic Acid
D014805	Vitamin B 12
D025101	Vitamin B 6

ID	Term
D011622	Pterins
D011621	Pteridines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring