VITRO-Trial. B Vitamins and the Secondary Prevention of Venous Thrombosis
Status:
Completed
Trial end date:
2003-01-01
Target enrollment:
Participant gender:
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.
Phase:
N/A
Details
Lead Sponsor:
Radboud University
Collaborator:
Netherlands Heart Foundation
Treatments:
Folic Acid Hydroxocobalamin Pyridoxine Vitamin B 12 Vitamin B Complex Vitamins