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Supplementary Vitamin B12 Effects on Elevated Homocysteine Levels of Vegetarians - Clinical Trial
Plain-language guide to NCT01661309: not phased randomized trial of Cyanocobalamin (Vitamin B12), 50 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01661309
- Phase
- not phased
- Status
- completed
- Start
- 2012-03
- Completion (planned or actual)
- 2014-05
- Participants
- 50 (actual)
- Design
- randomized, double-blind, prevention
- Conditions studied
- Vitamin B12 Deficiency
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (not phased) is built around Cyanocobalamin (Vitamin B12).
Vegetarians are known to be deficient in vitamin B12, due to a lack or absence of dietary animal produce, which can elevate homocysteine.
There is strong evidence indicating that elevated plasma total homocysteine (tHcy) is a contributor to chronic conditions, such as primary cardiovascular disease (CVD).
It had two arms (groups): Inactive lozenge (placebo comparator) and Methylcobalamin (experimental).
The registry classes the interventions as dietary supplement.
Who Took Part
Enrollment: 50 actual participants took part.
It was open to people of any sex aged from 18 years up to 65 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Having a plasma tHcy \>10 micromol/L. Not suffering from conditions as described in.
The full record lists 2 inclusion and 15 exclusion criteria; among the exclusions: vegetarian for at least one year; not consuming regularly vitamin b12 supplements; give written consent to participate in clinical trial and be fluent in english language.
How the Study Was Run
Design: randomized, parallel-group and double-blind.
Random assignment meant chance, not the researchers, decided who got Cyanocobalamin (Vitamin B12) and who got the comparison, which limits bias.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Blinding on both sides kept the participants and researchers unaware of who received Cyanocobalamin (Vitamin B12).
Those kept unaware of assignments: participant and investigator.
It started in 2012-03 with completion listed for 2014-05.
It ran at 1 site in United Kingdom.
Its stated primary purpose is prevention.
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of Cyanocobalamin (Vitamin B12) in 50 people.
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.