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Plain-language guide to NCT02773147: phase 2 randomized trial of Cyanocobalamin (Vitamin B12), 60 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02773147
- Phase
- phase 2
- Status
- status unknown
- Start
- 2016-04
- Completion (planned or actual)
- 2018-11
- Participants
- 60 (estimated)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- HIV
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 2 trial tested Cyanocobalamin (Vitamin B12).
It had two arms (groups): Triobe (experimental) and Control (no intervention).
The registry classes the interventions as drug.
Who Took Part
The registry lists 60 planned participants were the target.
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: The ability to understand and give informed consent to participate. HIV-1 infected with stable ART \> 12 months. Plasma HIV-RNA \< 50 copies/ml. Plasma homocysteine ≥ 12 μmol/L (subjects with \< 12 μmol/L will be included in the analysis of secondary endpoint 3 (see 5.4). Male or female, age 18 or older.
The full record lists 5 inclusion and 12 exclusion criteria; among the exclusions: treatment with trimethoprim-sulfamethoxazole or methotrexate; ongoing b6, b12 or folate substitution; antiepileptic treatment.
How the Study Was Run
Design: 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.
The Cyanocobalamin (Vitamin B12) group and the comparison group ran side by side rather than switching.
Nothing was hidden in this open-label Cyanocobalamin (Vitamin B12) study: the participants and staff both knew the treatment.
It started in 2016-04 with completion listed for 2018-11.
It ran at 1 site in Sweden.
Its stated primary purpose is treatment.
What This Means in Plain Language
Put simply, this is a phase 2, randomized trial of Cyanocobalamin (Vitamin B12) in 60 people.
Its status is unknown; 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.