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

Pulmonary Embolism Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00314990
• Other study ID #: NHS94.141
• Secondary ID: NHS99.055
• Status: Completed
• Phase: N/A
• First received: April 14, 2006
• Last updated: April 14, 2006
• Start date: January 1996
• Est. completion date: January 2003

Study information

• Verified date: April 2006
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 620
• Est. completion date: January 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Deep-Vein Thrombosis
• Embolism
• Pulmonary Embolism
• Thrombosis
• Venous Thrombosis

Intervention

Drug:
• 5 mg folic acid, 50 mg pyridoxine and 0.4 mg cyanocobalamin

Locations

Country	Name	City	State
Netherlands	Leyenburg Hospital (currently HAGA-hospital)	The Hague

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University	Netherlands Heart Foundation

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrent symptomatic DVT or recurrent PE.