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Sponsors and Collaborators: |
Radboud University Netherlands Heart Foundation |
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Information provided by: | Radboud University |
ClinicalTrials.gov Identifier: | NCT00314990 |
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.
Condition | Intervention |
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Deep-Vein Thrombosis Pulmonary Embolism |
Drug: 5 mg folic acid, 50 mg pyridoxine and 0.4 mg cyanocobalamin |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Homocysteine Lowering by B Vitamins and the Secondary Prevention of Deep-Vein Thrombosis and Pulmonary Embolism. A Randomized, Placebo-Controlled, Double Blind Trial. |
Ages Eligible for Study: | 20 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Netherlands | |
Leyenburg Hospital (currently HAGA-hospital) | |
The Hague, Netherlands, 2545 CH |
Principal Investigator: | Martin den Heijer, MD PhD | Radboud University |
Study Director: | Gerard MJ Bos, MD PhD | Maastricht University Medical Center |
Study ID Numbers: | NHS94.141, NHS99.055 |
Study First Received: | April 14, 2006 |
Last Updated: | April 14, 2006 |
ClinicalTrials.gov Identifier: | NCT00314990 |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Venous thrombosis Deep-vein thrombosis Pulmonary embolism Homocysteine |
B-vitamins Folate Vitamin B12 Vitamin B6 |
Pulmonary Embolism Hydroxocobalamin Vascular Diseases Vitamin B 12 Thrombosis Vitamin B 6 Folic Acid |
Embolism and Thrombosis Respiratory Tract Diseases Embolism Lung Diseases Neoplasm Metastasis Pyridoxine Venous Thrombosis |
Vitamin B Complex Growth Substances Vitamins Physiological Effects of Drugs |
Cardiovascular Diseases Micronutrients Pharmacologic Actions |