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

Radboud University Medical Center

Status

Completed

Conditions

Pulmonary Embolism

Deep-Vein Thrombosis

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT00314990

NHS99.055

NHS94.141

Details and patient eligibility

About

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.

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

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