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

NCT00314990 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 620

Last updated 2006-04-17

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

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

Sponsors & Collaborators

  • Netherlands Heart Foundation

    collaborator OTHER

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Martin den Heijer, MD PhD · Radboud University Medical Center

  • Gerard MJ Bos, MD PhD · Maastricht University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1996-01-31
Completion
2003-01-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00314990 on ClinicalTrials.gov