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Nutrition, Arsenic and Cognitive Function in Children
Plain-language guide to NCT03384862: not phased randomized trial of Cyanocobalamin (Vitamin B12), 239 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT03384862
- Phase
- not phased
- Status
- completed
- Start
- 2018-01-27
- Completion (planned or actual)
- 2019-05-09
- Participants
- 239 (actual)
- Design
- randomized, triple-blind, other
- Conditions studied
- Arsenic Exposure
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered not phased trial tested Cyanocobalamin (Vitamin B12).
The investigators will also explore whether folate and B12 can mitigate arsenic-related decrements in cognitive abilities.
It had two arms (groups): Nutritional Intervention Arm (experimental) and Control Arm (placebo comparator).
Placebo.
The registry classes the interventions as dietary supplement.
Who Took Part
The registry lists 239 actual participants took part.
It was open to people of any sex aged from 8 years up to 10 years.
Healthy volunteers could join, not only people with the condition.
The full record lists 1 inclusion and 4 exclusion criteria; among the exclusions: children who are not attending school; children with known physical disability or known chronic illness.
How the Study Was Run
It was run as a randomized, parallel-group and triple-blind study.
The participants were allocated by chance, so the Cyanocobalamin (Vitamin B12) group and the comparison group should start out alike.
Groups ran in parallel: each of the participants stayed in one arm throughout.
As a double-blind Cyanocobalamin (Vitamin B12) study, the assignments were hidden from both participants and investigators until the end.
Those kept unaware of assignments: participant, care provider and investigator.
It started in 2018-01-27 with completion listed for 2019-05-09.
It ran at 1 site in Bangladesh.
Its stated primary purpose is other.
What Was Measured
The main thing measured (primary outcome): Change in arsenic methylation (time frame: Up to 12 Weeks). Change in in blood arsenic (time frame: Up to 12 Weeks). Change in blood monomethyl arsenic (time frame: Up to 12 Weeks).
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of Cyanocobalamin (Vitamin B12) in 239 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.