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Influence of Different Doses of the Vitamin B12 on Recurrent Aphthous Stomatitis
Plain-language guide to NCT01127724: not phased randomized trial of Cyanocobalamin (Vitamin B12), 8 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01127724
- Phase
- not phased
- Status
- terminated early
- Start
- 2012-06
- Completion (planned or actual)
- 2014-10
- Participants
- 8 (actual)
- Design
- randomized, double-blind, treatment
- Conditions studied
- Recurrent Aphthous Stomatitis
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (not phased) is built around Cyanocobalamin (Vitamin B12).
It had three arms (groups): one (experimental), one (experimental) and one (experimental).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 8 actual participants took part.
It was open to people of any sex aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Patients aged 18 and older. Suffer from RAS For at least one year, with aphthous frequency at least once a month.
The full record lists 2 inclusion and 8 exclusion criteria; among the exclusions: known sensitivity to vitamin b12; don't speak hebrew, russian or english; systemic diseases, known in developing mouth aphthous (behcet disease, lupus erythematosus, rheumatoid arthritis and aids disease).
How the Study Was Run
Design: randomized, parallel-group and double-blind.
Because people in this Cyanocobalamin (Vitamin B12) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
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 care provider.
It started in 2012-06 with completion listed for 2014-10.
It ran at 1 site in Israel.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): frequency of recurrent aphthous stomatitis (RAS) (time frame: 12 months).
It also tracked 1 secondary outcome, for example severity of recurrent aphthous stomatitis (RAS).
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of Cyanocobalamin (Vitamin B12) in 8 people.
Its size is small, so on its own it can only give an early look.
It ended early (terminated); 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.