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

NCT ID: NCT00730509

Last Updated: 2008-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2006-03-31

Brief Summary

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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

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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.

Conditions

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Cystic Fibrosis

Keywords

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cystic fibrosis folate vitamin B12

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Interventions

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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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* cystic fibrosis

Exclusion Criteria

* diabetes
* chronic infections of the airways
* regular antibiotics intake
Minimum Eligible Age

3 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universita di Verona

OTHER

Sponsor Role lead

Responsible Party

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Verona University

Principal Investigators

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Lisa M. Bambara, MD

Role: STUDY_DIRECTOR

Verona University

Locations

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Verona University

Verona, , Italy

Site Status

Countries

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Italy

References

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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. doi: 10.1016/j.jcf.2006.01.006. Epub 2006 Mar 3.

Reference Type BACKGROUND
PMID: 16516563 (View on PubMed)

Scambi C, De Franceschi L, Guarini P, Poli F, Siciliano A, Pattini P, Biondani A, La Verde V, Bortolami O, Turrini F, Carta F, D'Orazio C, Assael BM, Faccini G, Bambara LM. Preliminary evidence for cell membrane amelioration in children with cystic fibrosis by 5-MTHF and vitamin B12 supplementation: a single arm trial. PLoS One. 2009;4(3):e4782. doi: 10.1371/journal.pone.0004782. Epub 2009 Mar 11.

Reference Type DERIVED
PMID: 19277125 (View on PubMed)

Other Identifiers

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UNIVR_REUM_01

Identifier Type: -

Identifier Source: org_study_id