Choline Nutrition in Children With Cystic Fibrosis

NCT01070446 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2010-02-18

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Cystic Fibrosis Foundation

    collaborator OTHER
  • University of British Columbia

    lead OTHER

Principal Investigators

  • Sheila M. Innis, Dr. · University of British Columbia

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2009-10-31
Completion
2010-02-28

Countries

  • Canada

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01070446 on ClinicalTrials.gov