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

Sponsors and Collaborators:	Radboud University Netherlands Heart Foundation
Information provided by:	Radboud University
ClinicalTrials.gov Identifier:	NCT00314990

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

MedlinePlus related topics: Deep Vein Thrombosis Pulmonary Embolism

Drug Information available for: Folic acid Vitamin B 12 Hydroxocobalamin Vitamin B 6 5-Hydroxy-6-methyl-3,4-pyridinedimethanol hydrochloride Pyridoxine Homocysteine

U.S. FDA Resources

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.

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

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

Publications indexed to this study:

den Heijer M, Willems HP, Blom HJ, Gerrits WB, Cattaneo M, Eichinger S, Rosendaal FR, Bos GM. Homocysteine lowering by B vitamins and the secondary prevention of deep vein thrombosis and pulmonary embolism: A randomized, placebo-controlled, double-blind trial. Blood. 2007 Jan 1;109(1):139-44. Epub 2006 Sep 7.

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)

Keywords provided by Radboud University:

Venous thrombosis
Deep-vein thrombosis
Pulmonary embolism
Homocysteine

B-vitamins
Folate
Vitamin B12
Vitamin B6

Study placed in the following topic categories:

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

Additional relevant MeSH terms:

Vitamin B Complex
Growth Substances
Vitamins
Physiological Effects of Drugs

Cardiovascular Diseases
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009