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Impact of Vitamin B12 Replacement on Epogen Dosing and Improvement of Quality of Life in Hemodialysis Patients
Plain-language guide to NCT01876732: not phased interventional trial of Cyanocobalamin (Vitamin B12), 132 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01876732
- Phase
- not phased
- Status
- completed
- Start
- 2009-06
- Completion (planned or actual)
- 2011-04
- Participants
- 132 (actual)
- Design
- na, open label (everyone knows who gets what)
- Conditions studied
- Vitamin B12 Deficiency
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
In this not phased trial, researchers set out to test Cyanocobalamin (Vitamin B12).
When vitamin B12 is deficient, abnormal red blood cells form.
These cells are called megaloblasts.
It had 1 arm (groups): Vitamin B12 (experimental).
The registry classes the interventions as drug.
More on the Plan
METHODS: Serum vitamin B12 and methylmalonic acid (MMA) levels were drawn from ESRD patients prior to hemodialysis.
Those with confirmatory smears were considered to be deficient and received intramuscular vitamin B12 injections for 4 months.
Post-treatment MMA levels and smears were obtained.
Erythropoietin dosages were monitored throughout the treatment period.
Who Took Part
The registry lists 132 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.
Examples of who could join: · Patients on Hemodialysis for at least 6 months.
The full record lists 2 inclusion and 9 exclusion criteria; among the exclusions: · on b12 treatment; hematological cancer; methotrexate use.
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 2009-06 with completion listed for 2011-04.
It ran at 1 site in United States.
What Was Measured
Researchers chose this as the main measure: Change in Amount of Epogen Required (time frame: Baseline and 4 months).
It also tracked 1 secondary outcome, for example Change in Quality of Life.
What This Means in Plain Language
Put simply, this is a not phased trial of Cyanocobalamin (Vitamin B12) in 132 people.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
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.