VITRO-Trial. B Vitamins and the Secondary Prevention of Venous Thrombosis
- Conditions
- Deep-Vein ThrombosisPulmonary Embolism
- Registration Number
- NCT00314990
- Lead Sponsor
- Radboud University Medical Center
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 620
- 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
- obligatory use of vitamin B
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Recurrent symptomatic DVT or recurrent PE.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Leyenburg Hospital (currently HAGA-hospital)
🇳🇱The Hague, Netherlands