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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00686361 |
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Date of registration:
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26/05/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Choline Nutrition in Children With Cystic Fibrosis (CF)
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Scientific title:
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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 |
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Date of first enrolment:
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October 2007 |
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Target sample size:
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34 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00686361 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Canada
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Contacts
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Name:
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Sheila M. Innis, Ph.D |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of British Columbia |
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Key inclusion & exclusion criteria
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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.
Age minimum:
5 Years
Age maximum:
17 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cystic Fibrosis
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Intervention(s)
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Drug: Choline supplementation
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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Measured at: 0, 3 and 6 mth and 9 mth a) inflammatory markers (IL-8, IL-6. IL-1ß, TNFa) 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]
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Secondary ID(s)
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H06-70444
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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