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

Cystic Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00730509
• Other study ID #: UNIVR_REUM_01
• Status: Completed
• Phase: N/A
• First received: August 4, 2008
• Last updated: August 4, 2008
• Start date: April 2004
• Est. completion date: March 2006

Study information

• Verified date: May 2008
• Source: Universita di Verona
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: March 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Years to 8 Years

Eligibility

Inclusion Criteria:

• cystic fibrosis

Exclusion Criteria:

• diabetes

• chronic infections of the airways

• regular antibiotics intake

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Dietary Supplement:
• 5-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

Locations

Country	Name	City	State
Italy	Verona University	Verona

Sponsors (1)

Lead Sponsor	Collaborator
Universita di Verona

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Scambi C, Guarini P, De Franceschi L, Bambara LM. Can 5-methyltetrahydrofolate modify the phospholipid fatty acid pattern in cystic fibrosis pediatric patients? J Cyst Fibros. 2006 Aug;5(3):197-9. Epub 2006 Mar 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	We evaluated membrane protein oxidative damage of red cells		6 months	No
Secondary	we evaluated cation transport pathways of red cells		6 months	No