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

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: NCT01150136
Recruitment Status : Completed
First Posted : June 24, 2010
Last Update Posted : April 22, 2015
Cystic Fibrosis Foundation Therapeutics
Information provided by (Responsible Party):
University of British Columbia

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.

Condition or disease
Cystic Fibrosis

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.

Study Type : Observational
Actual Enrollment : 57 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Choline Nutritional Status Of Children With Cystic Fibrosis X-Sectional Study
Study Start Date : October 2007
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. The relationship between choline and acetylcholine, and markers of oxidative stress, inflammation and disturbed methyl metabolism [ Time Frame: 12 months ]

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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
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

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.

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): NCT01150136

Canada, British Columbia
Child & Family Research Institute, CF Clinic, BC Children's Hospital
Vancouver, British Columbia, Canada
Sponsors and Collaborators
University of British Columbia
Cystic Fibrosis Foundation Therapeutics
Principal Investigator: Sheila M. Innis, Dr. University of British Columbia
Study Director: A. George F. Davidson, MD University of British Columbia

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University of British Columbia Identifier: NCT01150136     History of Changes
Other Study ID Numbers: H07-01140
First Posted: June 24, 2010    Key Record Dates
Last Update Posted: April 22, 2015
Last Verified: April 2015

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

Additional relevant MeSH terms:
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Lipotropic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Lipid Regulating Agents
Nootropic Agents