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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by University of British Columbia
Sponsor:
Collaborator:
Cystic Fibrosis Foundation
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01150136
First received: April 26, 2010
Last updated: December 20, 2012
Last verified: December 2012
  Purpose

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.


Condition
Cystic Fibrosis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Choline Nutritional Status Of Children With Cystic Fibrosis X-Sectional Study

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • The change in plasma choline and its metabolites with increasing age in children with CF compared to a healthy reference group without CF [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The relationship between choline and acetylcholine, and markers of oxidative stress, inflammation and disturbed methyl metabolism [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: October 2007
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Children with proven CF and known genotype, age 0-17 yr

Detailed Description:

The objective of this clinical project is to determine the status of choline and related metabolites in a large group of children with Cystic Fibrosis (CF). Based on the results it will be possible to determine which children are deficient or at risk for choline deficiency, and might benefit most from supplementation to sustain improvement in the plasma choline, and its metabolites. This will be a cross-sectional study that will, over a 6 month period, look to enroll as many patients as possible from 140 children with CF who are seen regularly at the CF Clinic at B.C.'s Children's Hospital. The study will involve the collection of blood and urine at the time of a scheduled appointment. All procedures for enrollment, collection of chart data and blood samples will follow procedures used in our previous studies. Body weight and height will be measured and routine blood work including liver enzymes, hematology, serum zinc, selenium and vitamins A and E will be completed as part of the clinic appointment. CF genotype, gender, birth date, hematology, clinical chemistry, anthropometric and nutritional measures, liver ultrasound, biopsy reports where available, pancreatic function (elastase, chymotrypsin/secretin-CCK) and all medications including mineral, vitamin and nutritional and enzyme supplements will be recorded from chart data. Blood samples will be used for analyses of choline and its metabolites and various biomarkers in redox pathways. A urine sample will be collected and used to assay excretion of related metabolites. Creatine will be analyzed to avoid the need for quantitative 24 hour urine collection.

  Eligibility

Ages Eligible for Study:   up to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01150136

Contacts
Contact: Sheila M. Innis, Dr. 604-875-2431 sinnis@interchange.ubc.ca

Locations
Canada, British Columbia
Child & Family Research Institute, CF Clinic, BC Children's Hospital Recruiting
Vancouver, British Columbia, Canada
Contact: Sheila M. Innis, Dr.    604-875-2431    sinnis@interchange.ubc.ca   
Sponsors and Collaborators
University of British Columbia
Cystic Fibrosis Foundation
Investigators
Principal Investigator: Sheila M. Innis, Dr. University of British Columbia
Study Director: A. George F. Davidson, MD University of British Columbia
  More Information

No publications provided by University of British Columbia

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01150136     History of Changes
Other Study ID Numbers: H07-01140
Study First Received: April 26, 2010
Last Updated: December 20, 2012
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
choline
cystic fibrosis
methyl metabolism
oxidative stress

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
Choline
Lipotropic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Gastrointestinal Agents
Therapeutic Uses
Lipid Regulating Agents
Nootropic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 21, 2014