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

Brief Summary

Official Title: “Homocysteine Lowering by B Vitamins and the Secondary Prevention of Deep-Vein Thrombosis and Pulmonary Embolism. A Randomized, Placebo-Controlled, Double Blind Trial.”

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.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Interventions Used in this Clinical Trial

  • Drug: 5 mg folic acid, 50 mg pyridoxine and 0.4 mg cyanocobalamin

Outcome Measures for this Clinical Trial

Primary Measures

  • Recurrent symptomatic DVT or recurrent PE.

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Radboud University
  • Collaborator
    • Netherlands Heart Foundation
  • Overall Official(s)
    • Martin den Heijer, MD PhD, Principal Investigator, Radboud University
    • Gerard MJ Bos, MD PhD, Study Director, Maastricht University Medical Center

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00314990