VITRO-Trial. B Vitamins and the Secondary Prevention of V... | NCT00314990

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

NCT00314990

Sponsor

Radboud University Medical Center

Status

Completed

Last Update Posted

Apr 17, 2006Estimated

Enrollment

620

Phase

Not Applicable

Conditions

Deep-Vein Thrombosis
Pulmonary Embolism

Interventions

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

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
NHS99.055

Status Module

Record Verification Date

Apr 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1996

Primary Completion Date

Not provided

Completion Date

Jan 2003

First Submitted Date

Apr 14, 2006

First Submission Date that Met QC Criteria

Apr 14, 2006

First Posted Date

Apr 17, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 14, 2006

Last Update Posted Date

Apr 17, 2006Estimated

Name	Class
Netherlands Heart Foundation	OTHER

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

620

Name	Type	Description	Arm Group Labels	Other Names
5 mg folic acid, 50 mg pyridoxine and 0.4 mg cyanocobalamin	Drug

Measure	Description	Time Frame
Recurrent symptomatic DVT or recurrent PE.

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Leyenburg Hospital (currently HAGA-hospital)		The Hague		2545 CH	Netherlands

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16960155	Derived	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.

ID	Term
D013927	Thrombosis
D016769	Embolism and Thrombosis
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

ID	Term
D005492	Folic Acid
D011736	Pyridoxine
D014805	Vitamin B 12

ID	Term
D011622	Pterins
D011621	Pteridines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

ID	Term
D020246	Venous Thrombosis
D011655	Pulmonary Embolism