Homocysteine Lowering by B Vitamins and the Secondary Prevention of Deep-Vein Thrombosis and Pulmonary Embolism. A Randomized, Placebo-Controlled, Double Blind Trial.
Sponsor study identifier
Secondary identifiers
interventional
620
1 country
1
Study Start
January 1996
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
January 2003
Date type not reportedThis date has not been verified as actual or estimated.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2003
Date type not reportedThis date has not been verified as actual or estimated.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1996
Date type not reportedThis date has not been verified as actual or estimated.
January 2003
Date type not reportedThis date has not been verified as actual or estimated.
April 14, 2006
Actual (reported)April 17, 2006
Actual (reported)Recurrent symptomatic DVT or recurrent PE.
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These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
5 mg folic acid, 50 mg pyridoxine and 0.4 mg cyanocobalamin
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordLeyenburg Hospital (currently HAGA-hospital)
The Hague, 2545 CH, Netherlands
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. doi: 10.1182/blood-2006-04-014654. Epub 2006 Sep 7.
Martin den Heijer, MD PhD
Radboud University Medical Center
Gerard MJ Bos, MD PhD
Maastricht University Medical Center
First Submitted
April 14, 2006
First Posted
April 17, 2006
Study Start
January 1996
Date type not reportedThis date has not been verified as actual or estimated.
Study Completion
January 2003
Date type not reportedOnce Daily Enoxaparin for Outpatient Treatment of Acute DVT and/or Pulmonary Embolism
Contact the study team to confirm eligibility.
This date has not been verified as actual or estimated.
Last Updated
April 17, 2006
Record last verified: 2006-04
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Source: ClinicalTrials.gov.
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