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

April 21, 2015 updated by: University of British Columbia
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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

57

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Child & Family Research Institute, CF Clinic, BC Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 17 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1
Children with proven CF and known genotype, age 0-17 yr

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
The relationship between choline and acetylcholine, and markers of oxidative stress, inflammation and disturbed methyl metabolism
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Collaborators

Cystic Fibrosis Foundation

Investigators

  • Study Director: A. George F. Davidson, MD, University of British Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (ACTUAL)

March 1, 2009

Study Completion (ACTUAL)

March 1, 2009

Study Registration Dates

First Submitted

April 26, 2010

First Submitted That Met QC Criteria

June 23, 2010

First Posted (ESTIMATE)

June 24, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

April 22, 2015

Last Update Submitted That Met QC Criteria

April 21, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H07-01140

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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