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

This study has been completed.
Sponsor:
Collaborator:
Netherlands Heart Foundation
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00314990
First received: April 14, 2006
Last updated: NA
Last verified: April 2006
History: No changes posted
  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.

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Recurrent symptomatic DVT or recurrent PE.

Estimated Enrollment: 620
Study Start Date: January 1996
Estimated Study Completion Date: January 2003
  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00314990

Locations
Netherlands
Leyenburg Hospital (currently HAGA-hospital)
The Hague, Netherlands, 2545 CH
Sponsors and Collaborators
Radboud University
Netherlands Heart Foundation
Investigators
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:
Thrombosis
Embolism
Pulmonary Embolism
Venous Thrombosis
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Thromboembolism
Vitamins
Vitamin B Complex
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014