Choline Nutrition in Children With Cystic Fibrosis

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: NCT01070446
Recruitment Status : Completed
First Posted : February 18, 2010
Last Update Posted : February 18, 2010
Cystic Fibrosis Foundation Therapeutics
Information provided by:
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 supply a choline supplement to children with CF to see if their nutrition and methyl status can be improved.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Dietary Supplement: Vitamin: Choline Bitartrate (2-hydroxyethyl) trimethylammonium salt 1:1 Not Applicable

Detailed Description:

This will be a prospective, repeated measures study involving 34 children with CF who will take a supplement of water soluble choline bitartrate, 2 gm/day with meals for 6 months. The baseline (day 0) results for each child will serve as his/her own control, and assessments will be made at 3 months and 6 months choline supplementation and again 3 months after stopping choline.

The supplement will be provided as capsules containing 250 mg choline bitartrate. 4 capsules will be taken with or immediately before each of two meals per day: breakfast and dinnertime meals, providing 1 gm of supplemental choline each day.

The children will be enrolled by description of the project to the child and their parent(s) at a CF clinic appointment. Body weight, height and blood pressure 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. The hematology and clinical chemistry will be done by the Hematopathology and Clinical Chemistry labs at the B.C.'s Children's Hospital. CF genotype, gender, birth date, hematology, clinical chemistry, anthropometry, nutritional measures, pulmonary function test results, chest X-Ray and/or CT scans, pancreatic function test results (fecal elastase, chymotrypsin or secretin-CCK), medications and supplements (including enzymes, vitamins, minerals, nutrition supplements & Natural Health Products) and where available, liver ultrasound and biopsy reports will be collected from chart data. Information in the subject's medical charts relating to antibiotic therapy, duration of illnesses, hospitalization and diagnosis will be reviewed to ensure the inclusion/exclusion criteria are met.

Assessment of pulmonary function by computer assisted spirometry which includes the measures of forced vital capacity (FVC), forced expiratory volume in one second (FEV1) and forced mid-expiratory flow (FEF 25-75) is completed for all children as part of each regularly scheduled clinic visit and the results collected for this study.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Choline Nutrition in Children With Cystic Fibrosis
Study Start Date : October 2007
Actual Primary Completion Date : October 2009
Actual Study Completion Date : February 2010

Arm Intervention/treatment
Experimental: 1
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
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.

Primary Outcome Measures :
  1. plasma choline, SAM, SAM/SAH ratio, homocysteine, GSH and the GSH/GSSG [ Time Frame: 9 months ]

Secondary Outcome Measures :
  1. (2-hydroxyethyl) trimethylammonium salt (1:1) [ Time Frame: 9 months ]

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Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

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): NCT01070446

Canada, British Columbia
Child & Family Research Institute, CF Clinic
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

Responsible Party: Dr. Sheila M. Innis, University of British Columbia Identifier: NCT01070446     History of Changes
Other Study ID Numbers: H06-7044
First Posted: February 18, 2010    Key Record Dates
Last Update Posted: February 18, 2010
Last Verified: February 2010

Keywords provided by University of British Columbia:
cystic fibrosis
methyl metabolism
fatty acids
oxidative stress
pulmonary function

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