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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00730509
Recruitment Status : Completed
First Posted : August 8, 2008
Last Update Posted : August 8, 2008
Information provided by:
Universita di Verona

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

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Dietary Supplement: 5-methyltetrahydrofolate and vitamin B12 Not Applicable

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 : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : April 2004
Actual 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

Primary Outcome Measures :
  1. We evaluated membrane protein oxidative damage of red cells [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. we evaluated cation transport pathways of red cells [ Time Frame: 6 months ]

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Ages Eligible for Study:   3 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • cystic fibrosis

Exclusion Criteria:

  • diabetes
  • chronic infections of the airways
  • regular antibiotics intake

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00730509

Verona University
Verona, Italy, 37134
Sponsors and Collaborators
Universita di Verona
Study Director: Lisa M. Bambara, MD Verona University

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Prof. Lisa Maria Bambara, Verona University Identifier: NCT00730509     History of Changes
Other Study ID Numbers: UNIVR_REUM_01
First Posted: August 8, 2008    Key Record Dates
Last Update Posted: August 8, 2008
Last Verified: May 2008

Keywords provided by Universita di Verona:
cystic fibrosis
vitamin B12

Additional relevant MeSH terms:
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Vitamin B 12
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs