Deep-Vein ThrombosisNCT00314990
VITRO-Trial. B Vitamins and the Secondary Prevention of Venous Thrombosis
A study testing 5 mg folic acid, 50 mg pyridoxine and 0.4 mg cyanocobalamin in people with Deep-Vein Thrombosis and Pulmonary Embolism, run by Radboud University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Deep-Vein Thrombosis, Pulmonary Embolism
- What is being tested?
- 5 mg folic acid, 50 mg pyridoxine and 0.4 mg cyanocobalamin
- How many people
- 620 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 1996to Jan 2003
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- obligatory use of vitamin B
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Leyenburg Hospital (currently HAGA-hospital)
The Hague, 2545 CH
About this study
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.
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
- Being tested
- 5 mg folic acid, 50 mg pyridoxine and 0.4 mg cyanocobalamin
- Keywords
- Venous thrombosis, Deep-vein thrombosis, Pulmonary embolism, Homocysteine, B-vitamins, Folate, Vitamin B12, Vitamin B6
- Medical subject headings
- Venous Thrombosis, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5 mg folic acid, 50 mg pyridoxine and 0.4 mg cyanocobalaminDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrent symptomatic DVT or recurrent PE.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2006 (estimated)
- Study startJan 1996
- Study completionJan 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Deep-Vein ThrombosisStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 620 participants
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Netherlands Heart Foundation
- Investigators
- Martin den Heijer, MD PhD, Principal investigator, Radboud University Medical CenterGerard MJ Bos, MD PhD, Study director, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00314990
- Sponsor's protocol ID
- NHS94.141
- Other IDs
- NHS99.055
- Status last verified
- Apr 2006
- First submitted
- 14 Apr 2006
- Last updated
- 17 Apr 2006
- Results posted
- No
Publications
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.
PubMed 16960155
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00314990
- Acronym / sponsor ID
- NHS94.141
- Conditions
- Deep-Vein Thrombosis, Pulmonary Embolism
- Keywords
- Venous thrombosis, Deep-vein thrombosis, Pulmonary embolism, Homocysteine, B-vitamins, Folate, Vitamin B12, Vitamin B6
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 620 participants
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Netherlands Heart Foundation
- Study start
- Jan 1996
- Study completion
- Jan 2003
- First posted
- 17 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- obligatory use of vitamin B
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5 mg folic acid, 50 mg pyridoxine and 0.4 mg cyanocobalamin | Drug | – |
Primary outcome
Recurrent symptomatic DVT or recurrent PE.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2006.
- Derived from this study: PubMed 16960155den 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin den Heijer, MD PhD principal investigator
Radboud University Medical Center
Gerard MJ Bos, MD PhD study director
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5 mg folic acid, 50 mg pyridoxine and 0.4 mg cyanocobalamin in people with Deep-Vein Thrombosis and Pulmonary Embolism, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrent symptomatic DVT or recurrent PE.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00314990, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2006.