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Effects of 5-Methyltetrahydrofolate and Vitamin B12 Supplemetation on Red Cell Membrane in Children With Cystic Fibrosis
Plain-language guide to NCT00730509: not phased interventional trial of Cyanocobalamin (Vitamin B12), 31 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00730509
- Phase
- not phased
- Status
- completed
- Start
- 2004-04
- Completion (planned or actual)
- 2006-03
- Participants
- 31 (actual)
- Design
- na, open label (everyone knows who gets what)
- Conditions studied
- Cystic Fibrosis
- 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 whether 5 - methyltetrahydrofolate and vitamin B12 supplementation can ameliorate cell plasma membrane features in pediatric patients with cystic fibrosis.
The registry classes the interventions as dietary supplement.
More on the Plan
Cystic fibrosis (CF) is one of the most common fatal autosomal recessive disorders in the Caucasian population caused by mutations of gene for the cystic fibrosis transmembrane conductance regulator (CFTR).
New experimental therapeutic strategies for CF propose a diet supplementation to affect the plasma membrane fluidity and to modulate the cellular amplified inflammatory response in CF target organs.
Red blood cells (RBCs) were used to investigate plasma membrane, because RBCs share lipid, protein composition and organization with other cell types.
Who Took Part
Enrollment: 31 actual participants took part.
It was open to people of any sex aged from 3 years up to 8 years.
Healthy volunteers could join, not only people with the condition.
The full record lists 1 inclusion and 3 exclusion criteria; among the exclusions: chronic infections of the airways; regular antibiotics intake.
How the Study Was Run
Design: single-group and open-label.
Nothing was hidden in this open-label Cyanocobalamin (Vitamin B12) study: the participants and staff both knew the treatment.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2004-04 with completion listed for 2006-03.
It ran at 1 site in Italy.
What Was Measured
Researchers chose this as the main measure: We evaluated membrane protein oxidative damage of red cells (time frame: 6 months).
It also tracked 1 secondary outcome, for example we evaluated cation transport pathways of red cells.
What This Means in Plain Language
Put simply, this is a not phased trial of Cyanocobalamin (Vitamin B12) in 31 people.
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, 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.