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Megadose of Hydroxocobalamin for the Treatment of Pernicious Anemia
Plain-language guide to NCT03372447: phase 4 interventional trial of Cyanocobalamin (Vitamin B12), anemia, 13 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT03372447
- Phase
- phase 4
- Status
- completed
- Start
- 2017-12-27
- Completion (planned or actual)
- 2018-12-01
- Participants
- 13 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Megaloblastic Anemia Nos; Pernicious Anemia
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 4 trial tested Cyanocobalamin (Vitamin B12) for anemia.
It had 1 arm (groups): Megadose multivitamin complex (experimental).
The registry classes the interventions as drug.
More on the Plan
To assess response to treatment, a complete blood count (CBC) will be performed weekly during the first month of treatment, after the first month a CBC will be taken monthly for 6 months.
Also to confirm the diagnosis and assess response the investigators will measure levels of methylmalonic acid, homocysteine, and hydroxocobalamin at the beginning of the study, 3 and 6 months.
Who Took Part
The registry lists 13 actual participants took part.
It was open to people of any sex aged from 18 years up to 90 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
How the Study Was Run
The set-up was single-group and open-label.
Everyone knew when Cyanocobalamin (Vitamin B12) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2017-12-27 with completion listed for 2018-12-01.
It ran at 1 site in Mexico.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Hematologic response (time frame: 2 month). Duration of hematologic response (time frame: 6 months).
It also tracked 4 secondary outcomes, for example Measure levels of hydroxocobalamin, Measure levels of methylmalonic acid, Measure levels of homocysteine and Evaluate time to hematologic response.
What This Means in Plain Language
Put simply, this is a phase 4 trial of Cyanocobalamin (Vitamin B12) in 13 people with anemia.
Its size is small, so on its own it can only give an early look.
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, Anemia research.
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.