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VITRO-Trial. B Vitamins and the Secondary Prevention of Venous Thrombosis
Plain-language guide to NCT00314990: not phased randomized trial of Cyanocobalamin (Vitamin B12), 620 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00314990
- Phase
- not phased
- Status
- completed
- Start
- 1996-01
- Completion (planned or actual)
- 2003-01
- Participants
- 620
- Design
- randomized, double-blind, prevention
- Conditions studied
- Deep-Vein Thrombosis; Pulmonary Embolism
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered not phased trial tested Cyanocobalamin (Vitamin B12).
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).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 620 planned participants were the target.
It was open to people of any sex aged from 20 years up to 80 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could 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.
The full record lists 3 inclusion and 1 exclusion criteria; among the exclusions: obligatory use of vitamin b.
How the Study Was Run
Design: randomized, parallel-group and double-blind.
The participants were allocated by chance, so the Cyanocobalamin (Vitamin B12) group and the comparison group should start out alike.
The Cyanocobalamin (Vitamin B12) group and the comparison group ran side by side rather than switching.
Neither the participants nor the staff measuring them knew who was on Cyanocobalamin (Vitamin B12), so expectations could not easily colour the readings.
It started in 1996-01 with completion listed for 2003-01.
It ran at 1 site in Netherlands.
Its stated primary purpose is prevention.
What Was Measured
The main thing measured (primary outcome): Recurrent symptomatic DVT or recurrent PE.
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of Cyanocobalamin (Vitamin B12) in 620 people.
With 620 participants it is a large trial for this field.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Cyanocobalamin (Vitamin B12) compound page, all human trials.
Our Notes on the Compound
Cyanocobalamin (Vitamin B12): A synthetic form of vitamin B12 (cobalamin), an essential nutrient for DNA synthesis, red blood cell formation and neurological function.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.