Choline Nutritional Status Of Children With Cystic Fibrosis X-Sectional Study

NCT01150136 | Completed

• 1 other identifier: H07-01140
• Study Type: observational
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

Cystic fibrosis (CF) is the most common lethal, inherited disorder among Caucasians. Choline is an essential vitamin and as a methyl donor is critically needed to support the normal metabolism. Our previous studies have demonstrated that children with CF have depleted levels of choline. The purpose of this study is to gather data on the status of choline and related metabolites in children with Cystic Fibrosis by age and gender. The hypothesis for this study is that in children with CF, deficiency of choline and related metabolites will increase with increasing age.

Conditions

Cystic Fibrosis

Keywords

choline; cystic fibrosis; methyl metabolism; oxidative stress

Outcome Measures

Primary Outcomes (1)

• The change in plasma choline and its metabolites with increasing age in children with CF compared to a healthy reference group without CF

  12 months

Secondary Outcomes (1)

• The relationship between choline and acetylcholine, and markers of oxidative stress, inflammation and disturbed methyl metabolism

  12 months

Study Arms (1)

1

Children with proven CF and known genotype, age 0-17 yr

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children with proven CF and known genotype, age 0-17 yr who are outpatients of the CF Clinic at the British Columbia (B.C.) Children's Hospital

You may qualify if:

• children with proven CF and known genotype.
• age 0-17 yr.
• outpatients of the CF Clinic at the British Columbia (B.C.) Children's Hospital.
• Children without CF or any other known disease.

You may not qualify if:

• children with CF receiving parenteral nutrition during the previous week.
• children who are hospitalized.
• children with any health problems other than CF that might in the opinion of the investigators influence dietary choices, growth, choline or methyl metabolites.

Sponsors & Collaborators

• University of British Columbia: lead
• Cystic Fibrosis Foundation: collaborator

Study Sites (1)

Child & Family Research Institute, CF Clinic, BC Children's Hospital

Vancouver, British Columbia, Canada

Location

Related Publications (1)

• Innis SM, Davidson AG, Bay BN, Slack PJ, Hasman D. Plasma choline depletion is associated with decreased peripheral blood leukocyte acetylcholine in children with cystic fibrosis. Am J Clin Nutr. 2011 Mar;93(3):564-8. doi: 10.3945/ajcn.110.005413. Epub 2011 Jan 12.

  PMID: 21228267 DERIVED

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Sheila M. Innis, Dr.

  University of British Columbia

  PRINCIPAL INVESTIGATOR

• A. George F. Davidson, MD

  University of British Columbia

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2010
• First Posted: June 24, 2010
• Study Start: October 1, 2007
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: April 22, 2015

Record last verified: 2015-04

Locations

CA (1)