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

NCT00314990 | Completed

• 2 other identifiers: NHS94.141NHS99.055
• Study Type: interventional
• Target: 620
• Locations: 1 country
• Sites: 1

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.

Conditions

Deep-Vein Thrombosis; Pulmonary Embolism

Keywords

Venous thrombosis; Deep-vein thrombosis; Pulmonary embolism; Homocysteine; B-vitamins; Folate; Vitamin B12; Vitamin B6

Outcome Measures

Primary Outcomes (1)

• Recurrent symptomatic DVT or recurrent PE.

Interventions

5 mg folic acid, 50 mg pyridoxine and 0.4 mg cyanocobalamin DRUG

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• obligatory use of vitamin B

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Netherlands Heart Foundation: collaborator

Study Sites (1)

Leyenburg Hospital (currently HAGA-hospital)

The Hague, 2545 CH, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 16960155 DERIVED

MeSH Terms

Conditions

Venous Thrombosis; Pulmonary Embolism

Interventions

Folic Acid; Pyridoxine; Vitamin B 12

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Embolism

Intervention Hierarchy (Ancestors)

Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Vitamin B 6; Picolines; Pyridines; Heterocyclic Compounds, 1-Ring; Corrinoids; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 4 or More Rings; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Martin den Heijer, MD PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

• Gerard MJ Bos, MD PhD

  Maastricht University Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 14, 2006
• First Posted: April 17, 2006
• Study Start: January 1, 1996
• Study Completion: January 1, 2003
• Last Updated: April 17, 2006

Record last verified: 2006-04

Locations

NL (1)