VITRO-Trial. B Vitamins and the Secondary Prevention of Venous Thrombosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

620 participants

Study Classification

INTERVENTIONAL

Study Start Date

1996-01-31

Study Completion Date

2003-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The VITRO (Vitamins and Thrombosis) study investigated the effect of homocysteine lowering by daily supplementation of B-vitamins on the risk reduction of deep-vein thrombosis and pulmonary embolism. Patients between 20 to 80 years old with a first objectively confirmed proximal deep-vein thrombosis or pulmonary embolism in the absence of major risk factors and a homocysteine concentration above the 75th percentile of a reference group were asked to participate (hyperhomocysteinemic group). A similar study was conducted in a random sample of patients with a homocysteine below the 75th percentile of the reference group (normohomocysteinemic group). After informed consent patients were randomized to daily multivitamin supplementation (5 mg folic acid, 50 mg pyridoxine and 0.4 mg cyanocobalamin) or placebo and were followed for 2.5 years. End-points were objectively diagnosed recurrent deep-vein thrombosis or pulmonary embolism.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Deep-Vein Thrombosis Pulmonary Embolism

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

5 mg folic acid, 50 mg pyridoxine and 0.4 mg cyanocobalamin

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* objectively confirmed proximal deep-vein thrombosis or pulmonary embolism
* idiopathic thrombosis (i.e. absence of major risk factors (major surgery, known malignant disease, pregnancy and puerperium or immobility for more than three weeks)
* age between 20 to 80 years

Exclusion Criteria

* obligatory use of vitamin B

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Martin den Heijer, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Gerard MJ Bos, MD PhD

Role: STUDY_DIRECTOR

Maastricht University Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Leyenburg Hospital (currently HAGA-hospital)

The Hague, , Netherlands

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Netherlands

References

Explore related publications, articles, or registry entries linked to this study.

den Heijer M, Willems HP, Blom HJ, Gerrits WB, Cattaneo M, Eichinger S, Rosendaal FR, Bos GM. Homocysteine lowering by B vitamins and the secondary prevention of deep vein thrombosis and pulmonary embolism: A randomized, placebo-controlled, double-blind trial. Blood. 2007 Jan 1;109(1):139-44. doi: 10.1182/blood-2006-04-014654. Epub 2006 Sep 7.

Reference Type DERIVED

PMID: 16960155 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NHS99.055

Identifier Type: -

Identifier Source: secondary_id

NHS94.141