Deep-Vein Thrombosis, Pulmonary Embolism
Conditions
Keywords
Venous thrombosis, Deep-vein thrombosis, Pulmonary embolism, Homocysteine, B-vitamins, Folate, Vitamin B12, Vitamin B6
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.
Interventions
DRUG5 mg folic acid, 50 mg pyridoxine and 0.4 mg cyanocobalamin
Sponsors
Netherlands Heart Foundation
Radboud University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrent symptomatic DVT or recurrent PE. | — |
Countries
Netherlands
Outcome results
None listed