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Efficacy and Safety Study of Oral Eligen® B12 in Subjects With Low Serum Cobalamin
Plain-language guide to NCT01312831: not phased randomized trial of Cyanocobalamin (Vitamin B12), 49 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01312831
- Phase
- not phased
- Status
- completed
- Start
- 2009-02
- Completion (planned or actual)
- 2010-12
- Participants
- 49 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Vitamin B 12 Deficiency
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this not phased trial, researchers set out to test Cyanocobalamin (Vitamin B12).
It had two arms (groups): Oral Eligen® B12 (experimental) and IM B12 (active comparator).
The registry classes the interventions as other.
Who Took Part
The registry lists 49 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: Vitamin B12 deficiency defined as serum cobalamin below 350 pg/mL.
The full record lists 3 inclusion and 9 exclusion criteria; among the exclusions: current treatment from a health care provider to treat vitamin b12 deficiency and/or symptoms;; daily use of neutralizing antacids (e.g. maalox®); inability to ingest oral medication.
How the Study Was Run
The set-up was randomized, parallel-group and open-label.
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.
Nothing was hidden in this open-label Cyanocobalamin (Vitamin B12) study: the participants and staff both knew the treatment.
It started in 2009-02 with completion listed for 2010-12.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Serum Cobalamin Normalization (time frame: 61 days).
It also tracked 8 secondary outcomes, for example Maintenance of B12 Normalization, Time to Normalization, Percent Change from Baseline in Cobalamin Levels After 60 and 90 days of Treatment, Percent Change from Baseline in Methylmalonic Acid (MMA) Levels After 60 and 90 Days of Treatment, Percent Change from Baseline in Homocysteine Levels After 60 and 90 Days of Treatment and Number of Subjects with Adverse Events as a Measure of Safety and Tolerability.
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of Cyanocobalamin (Vitamin B12) in 49 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.