VITRO-Trial. B Vitamins and the Secondary Prevention of Venous Thrombosis
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 |
|---|---|
|
Deep-Vein Thrombosis Pulmonary Embolism |
Drug: 5 mg folic acid, 50 mg pyridoxine and 0.4 mg cyanocobalamin |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention |
| 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. |
Eligibility| Ages Eligible for Study: | 20 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations| 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 |
More Information
No publications provided by Radboud University
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00314990 History of Changes |
| Other Study ID Numbers: | NHS94.141, NHS99.055 |
| Study First Received: | April 14, 2006 |
| Last Updated: | April 14, 2006 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by Radboud University:
|
Venous thrombosis Deep-vein thrombosis Pulmonary embolism Homocysteine |
B-vitamins Folate Vitamin B12 Vitamin B6 |
Additional relevant MeSH terms:
|
Embolism Pulmonary Embolism Thrombosis Venous Thrombosis Venous Thromboembolism Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Lung Diseases Respiratory Tract Diseases Thromboembolism Folic Acid |
Vitamin B Complex Hydroxocobalamin Vitamin B 12 Pyridoxine Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Hematinics Hematologic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013