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

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ClinicalTrials.gov Identifier: NCT00314990
Recruitment Status : Completed
First Posted : April 17, 2006
Last Update Posted : April 17, 2006
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief 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.

Condition or disease Intervention/treatment
Deep-Vein Thrombosis Pulmonary Embolism Drug: 5 mg folic acid, 50 mg pyridoxine and 0.4 mg cyanocobalamin

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 620 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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.
Study Start Date : January 1996
Estimated Study Completion Date : January 2003


Arms and Interventions


Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: April 17, 2006    Key Record Dates
Last Update Posted: April 17, 2006
Last Verified: April 2006

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
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Vitamins
Folic Acid
Pyridoxine
Vitamin B 12
Hydroxocobalamin
Vitamin B Complex
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hematinics