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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
  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:

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:
    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
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:

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

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 June 18, 2013