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Effects of 5-Methyltetrahydrofolate and Vitamin B12 Supplemetation on Red Cell Membrane in Children With Cystic Fibrosis

Preliminary Evidences of Active Form of Folic Acid and Vitamin B12 Supplementation to Ameliorate Cell Membrane in Children With Cystic Fibrosis

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00730509
Enrollment
31
Registered
2008-08-08
Start date
2004-04-30
Completion date
2006-03-31
Last updated
2008-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis

Keywords

cystic fibrosis, folate, vitamin B12

Brief summary

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

Detailed description

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.

Interventions

DIETARY_SUPPLEMENT5-methyltetrahydrofolate and vitamin B12

children with cystic fibrosis were supplementated for 6 months with 5-MTHF, 7,5 mg/day ; vitamin B12, 0,5 mg/day

Sponsors

Universita di Verona
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
3 Years to 8 Years
Healthy volunteers
Yes

Inclusion criteria

* cystic fibrosis

Exclusion criteria

* diabetes * chronic infections of the airways * regular antibiotics intake

Design outcomes

Primary

MeasureTime frame
We evaluated membrane protein oxidative damage of red cells6 months

Secondary

MeasureTime frame
we evaluated cation transport pathways of red cells6 months

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 3, 2026