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

Not Applicable

Completed

• Conditions: Cystic Fibrosis

• Registration Number: NCT00730509
• Lead Sponsor: Universita di Verona

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.

Study Timeline

• Study Start: 2004-04
• Study Completion: 2006-03
• Status Verified: 2008-05
• Study First Submitted: 2008-08-04
• Study First Submitted QC: 2008-08-04
• Last Update Submitted: 2008-08-04
• Study First Posted: 2008-08-08
• Last Update Posted: 2008-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

• cystic fibrosis

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
We evaluated membrane protein oxidative damage of red cells	6 months

Secondary Outcome Measures

Name	Time	Method
we evaluated cation transport pathways of red cells	6 months

Trial Locations

Locations (1)

Verona University; 🇮🇹 Verona, Italy