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

Sponsor:	Universita di Verona
Information provided by:	Universita di Verona
ClinicalTrials.gov Identifier:	NCT00730509

Purpose

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

Condition	Intervention
Cystic Fibrosis	Dietary Supplement: 5-methyltetrahydrofolate and vitamin B12

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label
Official Title:	Preliminary Evidences of Active Form of Folic Acid and Vitamin B12 Supplementation to Ameliorate Cell Membrane in Children With Cystic Fibrosis

Resource links provided by NLM:

Genetics Home Reference related topics: cystic fibrosis

MedlinePlus related topics: B Vitamins Cystic Fibrosis

Drug Information available for: Folic acid Vitamin B 12 Hydroxocobalamin 5-Methyltetrahydrofolate

U.S. FDA Resources

Further study details as provided by Universita di Verona:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Enrollment:	31
Study Start Date:	April 2004
Study Completion Date:	March 2006

Intervention Details:

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

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.

Eligibility

Ages Eligible for Study:	3 Years to 8 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

cystic fibrosis

Exclusion Criteria:

diabetes
chronic infections of the airways
regular antibiotics intake

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00730509

Locations

Italy
Verona University
Verona, Italy, 37134

Sponsors and Collaborators

Universita di Verona

Investigators

Study Director:

Lisa M. Bambara, MD

Verona University

More Information

Publications:

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2009 Mar 11.

Responsible Party:	Prof. Lisa Maria Bambara, Verona University
ClinicalTrials.gov Identifier:	NCT00730509 History of Changes
Other Study ID Numbers:	UNIVR_REUM_01
Study First Received:	August 4, 2008
Last Updated:	August 4, 2008
Health Authority:	Italy: Ethics Committee

Keywords provided by Universita di Verona:

cystic fibrosis
folate
vitamin B12

Additional relevant MeSH terms:

Cystic Fibrosis
Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes
Vitamin B 12

Hydroxocobalamin
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematinics
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012