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

This study has been completed.

Sponsor:

Information provided by:

Universita di Verona

ClinicalTrials.gov Identifier:

NCT00730509

First received: August 4, 2008

Last updated: NA

Last verified: May 2008

History: No changes posted

Tracking Information

First Received Date ^ICMJE

August 4, 2008

Last Updated Date

August 4, 2008

Start Date ^ICMJE

April 2004

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

We evaluated membrane protein oxidative damage of red cells [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

we evaluated cation transport pathways of red cells [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: Open Label

Condition ^ICMJE

Cystic Fibrosis

Intervention ^ICMJE

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

Study Arm (s)

Not Provided

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

March 2006

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

cystic fibrosis

Exclusion Criteria:

diabetes
chronic infections of the airways
regular antibiotics intake

Gender

Both

Ages

3 Years to 8 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Italy

Administrative Information

NCT Number ^ICMJE

NCT00730509

Other Study ID Numbers ^ICMJE

UNIVR_REUM_01

Has Data Monitoring Committee

Responsible Party

Prof. Lisa Maria Bambara, Verona University

Study Sponsor ^ICMJE

Universita di Verona

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Lisa M. Bambara, MD

Verona University

Information Provided By

Universita di Verona

Verification Date

May 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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