Choline Nutrition in Children With Cystic Fibrosis

NCT01070446 | Completed

• 1 other identifier: H06-7044
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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 supply a choline supplement to children with CF to see if their nutrition and methyl status can be improved.

Conditions

Cystic Fibrosis

Keywords

choline; cystic fibrosis; methyl metabolism; fatty acids; oxidative stress; pulmonary function

Outcome Measures

Primary Outcomes (1)

• plasma choline, SAM, SAM/SAH ratio, homocysteine, GSH and the GSH/GSSG

  9 months

Secondary Outcomes (1)

• (2-hydroxyethyl) trimethylammonium salt (1:1)

  9 months

Study Arms (1)

1

EXPERIMENTAL

This study involves children with CF who will take a water soluble vitamin supplement of choline bitartrate, 2 gm per day with meals.

Dietary Supplement: Vitamin: Choline Bitartrate (2-hydroxyethyl) trimethylammonium salt 1:1

Interventions

Vitamin: Choline Bitartrate (2-hydroxyethyl) trimethylammonium salt 1:1 DIETARY_SUPPLEMENT

This is a prospective, repeated measures study involving children with Cystic Fibrosis. Children will be assessed (1) before starting the choline supplement, (2) after taking the supplement for 6 months and after the supplement has been discontinued for 3 months.

1

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• children aged 5-17 yr with proven CF and known genotype
• with stable pulmonary disease, are outpatients with no hospitalizations or changes to antibiotic regiment during the previous 1 month and not receiving any parenteral nutrition
• are non-smokers without asthma, may be taking routine fat soluble vitamins but must not be taking any supplemental fish oil, docosahexanoic acid (DHA) or choline containing compounds, experimental drugs or any aerosol or oral interventions designed to deliver or increase glutathione or receiving oral or parenteral corticosteroidal medications. E.g prednisone.

You may not qualify if:

• are not 5-17 years of age, do not have CF or have the medical condition trimethylaminuria.
• have CF, but have allergies to any of the ingredients in the choline supplements; are hospitalized; have asthma or are smokers; are taking oral or parenteral corticosteroidal medications or any intravenous nutritional support; have kidney or liver disease; or have a baseline FEV 1 of less than 50% predicted value (which at our clinic means they are likely hospitalized or about to be admitted to hospital).

Sponsors & Collaborators

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

Study Sites (1)

Child & Family Research Institute, CF Clinic

Vancouver, British Columbia, 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, Dr.

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 10, 2010
• First Posted: February 18, 2010
• Study Start: October 1, 2007
• Primary Completion: October 1, 2009
• Study Completion: February 1, 2010
• Last Updated: February 18, 2010

Record last verified: 2010-02

Locations

CA (1)