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Completed

NCT Number: NCT00730509

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

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

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

3 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Verona University

Verona, 37134, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • cystic fibrosis

Exclusion criteria

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

Treatment and study plan

5-methyltetrahydrofolate and vitamin B12

Dietary Supplement

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

Primary outcomes

  1. We evaluated membrane protein oxidative damage of red cells

    Time frame: 6 months

Secondary outcomes

  1. we evaluated cation transport pathways of red cells

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Universita di Verona

Other

Registry information

Official study title

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

Important dates

Study start
2004
Study completion
2006
First posted
Aug 8, 2008
Registry last updated
Aug 8, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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