NCT00314990

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 620 (planned)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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

• Deep-Vein Thrombosis
• Pulmonary Embolism

Interventions

Type	Name	Description
DRUG	5 mg folic acid, 50 mg pyridoxine and 0.4 mg cyanocobalamin

Timeline

• Start date: 1996-01-01
• Completion: 2003-01-01
• First posted: 2006-04-17
• Last updated: 2006-04-17

Locations

1 site across 1 country: Netherlands