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BVAIT: B-Vitamin Atherosclerosis Intervention Trial
Plain-language guide to NCT00114400: phase 2, phase 3 randomized trial of Cyanocobalamin (Vitamin B12), 506 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00114400
- Phase
- phase 2, phase 3
- Status
- completed
- Start
- 2000-11
- Completion (planned or actual)
- 2007-02
- Participants
- 506
- Design
- randomized, double-blind, treatment
- Conditions studied
- Atherosclerosis
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 2, phase 3) is built around Cyanocobalamin (Vitamin B12).
The registry classes the interventions as drug.
More on the Plan
Ultrasonography will be used to measure the rate of change in the thickness of the carotid artery and CT will be used to measure coronary and aortic calcium.
Participants will receive ultrasonography at baseline and every 6 months for 2.5 to 4.5 years, and CT scan at baseline and end of study (2.5 to 4.5 years).
Who Took Part
506 planned participants were the target.
It was open to people of any sex aged from 40 years with no upper age limit.
Healthy volunteers could join, not only people with the condition.
The full record lists 3 inclusion and 8 exclusion criteria; among the exclusions: any clinical signs or symptoms of cardiovascular disease (cvd); uncontrolled hypertension (systolic blood pressure 160 mmhg or greater and/or diastolic blood pressure 100 mmhg or greater); thyroid disease (untreated).
How the Study Was Run
It was run as a randomized, parallel-group and double-blind study.
Random assignment meant chance, not the researchers, decided who got Cyanocobalamin (Vitamin B12) and who got the comparison, which limits bias.
The Cyanocobalamin (Vitamin B12) group and the comparison group ran side by side rather than switching.
Blinding on both sides kept the participants and researchers unaware of who received Cyanocobalamin (Vitamin B12).
It started in 2000-11 with completion listed for 2007-02.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: rate of change of distal common carotid artery (CCA) far wall intima-media thickness (IMT).
It also tracked 2 secondary outcomes, for example change in coronary and abdominal aortic calcification and neurocognitive change.
What This Means in Plain Language
Put simply, this is a phase 2, phase 3, randomized trial of Cyanocobalamin (Vitamin B12) in 506 people.
With 506 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.