Choline Nutrition in Children With Cystic Fibrosis (CF)

NCT00686361 | Completed

• 1 other identifier: H06-70444
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis

Keywords

Cystic Fibrosis; choline nutrition; choline and methyl metabolism; CF and oxidative stress

Outcome Measures

Primary Outcomes (1)

• 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)

  9 months

Secondary Outcomes (1)

• 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)

  9 months

Interventions

Choline supplementation DRUG

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.

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children with Cystic Fibrosis of known genotype.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Nutrition Research Program, BC Children's Hospital

Vancouver, British Columbia, V6H 3V4, Canada

Location

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, Ph.D

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 26, 2008
• First Posted: May 29, 2008
• Study Start: October 1, 2007
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: June 8, 2011

Record last verified: 2011-06

Locations

CA (1)