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Completed

NCT Number: NCT00314990

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

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.

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Key information

Conditions

Deep-Vein Thrombosis Cardiovascular Diseases Embolism Embolism and Thrombosis Lung Diseases Pulmonary Embolism Respiratory Tract Diseases Thrombosis Vascular Diseases Venous Thrombosis

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Leyenburg Hospital (currently HAGA-hospital)

The Hague, 2545 CH, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

Primary outcomes

  1. Recurrent symptomatic DVT or recurrent PE.

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • Netherlands Heart Foundation

Registry information

Official study title

Homocysteine Lowering by B Vitamins and the Secondary Prevention of Deep-Vein Thrombosis and Pulmonary Embolism. A Randomized, Placebo-Controlled, Double Blind Trial.

Important dates

Study start
1996
Study completion
2003
First posted
Apr 17, 2006
Registry last updated
Apr 17, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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