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

Sponsor

Radboud University Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT00314990

Collaborator

Netherlands Heart Foundation (Other)

620

Enrollment

Location

Duration (Months)

7.4

Patients Per Site Per Month

Study Details

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	Phase
Deep-Vein Thrombosis Pulmonary Embolism	Drug: 5 mg folic acid, 50 mg pyridoxine and 0.4 mg cyanocobalamin	N/A

Study Design

Study Type:

Interventional

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 :

Jan 1, 1996

Study Completion Date :

Jan 1, 2003

Outcome Measures

Primary Outcome Measures

Recurrent symptomatic DVT or recurrent PE. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Leyenburg Hospital (currently HAGA-hospital)	The Hague		Netherlands	2545 CH

Sponsors and Collaborators

Radboud University Medical Center
Netherlands Heart Foundation

Investigators

Principal Investigator: Martin den Heijer, MD PhD, Radboud University Medical Center
Study Director: Gerard MJ Bos, MD PhD, Maastricht University Medical Center