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Choline Nutrition in Children With Cystic Fibrosis (CF)

Primary Purpose

Cystic Fibrosis

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Choline supplementation
Sponsored by
University of British Columbia
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis focused on measuring Cystic Fibrosis, choline nutrition, choline and methyl metabolism, CF and oxidative stress

Eligibility Criteria

5 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Children with Cystic Fibrosis of known genotype.

Exclusion Criteria:

  • No hospitalizations within the previous month
  • not receiving parenteral nutrition
  • FEV1 > 50% at enrollment
  • BMI and weight for age z-scores > 5th percentile
  • non smokers
  • no asthma
  • not taking any lipid supplement or other agent designed to effect glutathione status.

Sites / Locations

  • Nutrition Research Program, BC Children's Hospital

Outcomes

Primary Outcome Measures

Measured at: 0 (baseline), 3 and 6 mth (6 mth supplementation) and 9 mths (3 mth post supplementation) a) choline and methyl metabolites b) redox status (GSH/GSSG)

Secondary Outcome Measures

Measured at: 0, 3 and 6 mth and 9 mth a) inflammatory markers (IL-8, IL-6. IL-1ß, TNFα) b) essential n-6 and n-3 fatty acids c) pulmonary function (FVC, FEV1 (FEF 25-75) d) liver function (serum liver enzymes)

Full Information

First Posted
May 26, 2008
Last Updated
June 6, 2011
Sponsor
University of British Columbia
Collaborators
Cystic Fibrosis Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00686361
Brief Title
Choline Nutrition in Children With Cystic Fibrosis (CF)
Official Title
To Investigate Whether Choline Supplementation in Children With CF Will Correct Biochemical Markers of Choline Deficiency and Improve Plasma Indices of Methylation Capacity and Redox Status and Result in Decreased Pro-inflammatory Cytokines
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of British Columbia
Collaborators
Cystic Fibrosis Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Cystic Fibrosis (CF) is a complex disease with a wide range of clinical problems. Despite enzyme replacement therapy, children with cystic fibrosis (CF) may still have problems absorbing some nutrients. Detailed studies of the nutrient status of children with CF and have found low amounts of choline, an essential dietary nutrient, and altered levels of some amino acids in almost all patients. Choline is an essential dietary nutrient that is important in many important body functions, which include proving a source of methyl groups, the structure of cell membranes and in acetylcholine. Most choline is present in our diets in a fat known as phosphatidylcholine. Research studies have shown that children with cystic fibrosis do not absorb fat, including phosphatidylcholine very well. In previous studies, we showed that choline provided as a dietary supplement for 2 weeks improved choline status in children with cystic fibrosis. The purpose of this research is to find out if choline supplements over a longer duration of 6 months will improve and maintain normal choline status in children with CF.
Detailed Description
This is a prospective study involving 34 children attending an outpatient clinic for children with CF. After enrollment, subjects will be followed for 9 months with each child serving as their own control in a repeated measures design. Chart data, height, weight, pulmonary function, dietary intake and a venous blood and urine sample will be collected at enrollment then every 3 months for 9 months. Choline supplementation will be from enrollment for 6 months, with follow up at 3 months post supplementation. To avoid additional hospital visits and blood draws, and to co-ordinate with pulmonary function, hematology, clinical chemistry tests as part of clinical care, each subject will be seen at routine scheduled clinic appointments, which are every 3 months. The objectives are to determine if supplementation with choline for 6 months corrects biochemical markers of choline deficiency and improves indices of reduced methylation capacity (including methionine, SAM, SAM/SAH) and redox status (GSH/GSSG) based on measures of blood and urine determine whether or not choline supplementation decreases plasma pro-inflammatory mediators determine if choline supplementation improves the low n-6 and n-3 fatty acids levels in children with CF, explore if choline supplementation has the potential to have clinical relevance in reducing recurrent inflammation, and improve pulmonary function and/or reduce liver disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
Cystic Fibrosis, choline nutrition, choline and methyl metabolism, CF and oxidative stress

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Choline supplementation
Intervention Description
Chart data, height, weight, pulmonary function, dietary intake and a venous blood and urine sample will be collected at enrollment then every 3 months for 9 months. Choline supplementation will be from enrollment for 6 months, with follow up at 3 months post supplementation. To avoid additional hospital visits and blood draws, and to co-ordinate with pulmonary function, hematology, clinical chemistry tests as part of clinical care, each subject will be seen at routine scheduled clinic appointments, which are every 3 months.
Primary Outcome Measure Information:
Title
Measured at: 0 (baseline), 3 and 6 mth (6 mth supplementation) and 9 mths (3 mth post supplementation) a) choline and methyl metabolites b) redox status (GSH/GSSG)
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Measured at: 0, 3 and 6 mth and 9 mth a) inflammatory markers (IL-8, IL-6. IL-1ß, TNFα) b) essential n-6 and n-3 fatty acids c) pulmonary function (FVC, FEV1 (FEF 25-75) d) liver function (serum liver enzymes)
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children with Cystic Fibrosis of known genotype. Exclusion Criteria: No hospitalizations within the previous month not receiving parenteral nutrition FEV1 > 50% at enrollment BMI and weight for age z-scores > 5th percentile non smokers no asthma not taking any lipid supplement or other agent designed to effect glutathione status.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheila M. Innis, Ph.D
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nutrition Research Program, BC Children's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3V4
Country
Canada

12. IPD Sharing Statement

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Choline Nutrition in Children With Cystic Fibrosis (CF)

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