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Examining B12 Deficiency Associated With C677T Mutation on MTHFR Gene in Terms of Commonness and Endothelial Function
Plain-language guide to NCT00730574: not phased non-randomized trial of Cyanocobalamin (Vitamin B12), 100 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00730574
- Phase
- not phased
- Status
- terminated early
- Start
- 2008-07
- Completion (planned or actual)
- 2011-03
- Participants
- 100 (actual)
- Design
- non-randomized, open label (everyone knows who gets what), screening
- Conditions studied
- B12 Deficiency Combined With C677T Mutation on MTHFR Gene
- 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).
The purpose of this study is to determine the commonness of the C677T mutation in the MTHFR gene in subjects with B12 deficiency.
Also, the researchers'd like to investigate the effect of B12 deficiency combined with the C677T mutation on endothelial function.
It had two arms (groups): B (no intervention) and A (experimental).
The registry classes the interventions as dietary supplement.
Who Took Part
The registry lists 100 actual participants took part.
It was open to people of any sex aged from 20 years up to 60 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Adult males and females of the broad population aged 20-60. With no symptomatic heart disease/condition. Which have not received Vitamin B12 supplement treatment before.
The full record lists 4 inclusion and 3 exclusion criteria; among the exclusions: adults suffering from a known heart disease/condition; any disease the investigator might find as interfering with the process of the experiment; tumor-oriented diseases.
How the Study Was Run
It was run as a non-randomized, parallel-group and open-label study.
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 2008-07 with completion listed for 2011-03.
It ran at 1 site in Israel.
Its stated primary purpose is screening.
What This Means in Plain Language
Put simply, this is a not phased, non-randomized trial of Cyanocobalamin (Vitamin B12) in 100 people.
It ended early (terminated); 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.