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. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 February 2015 |
Main ID: |
NCT01187459 |
Date of registration:
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20/08/2010 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Vitamin D in Pediatric Crohn's Disease
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Scientific title:
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Vitamin D in Pediatric Crohn's Disease |
Date of first enrolment:
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September 2010 |
Target sample size:
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87 |
Recruitment status: |
Completed |
URL:
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http://clinicaltrials.gov/show/NCT01187459 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention
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Phase:
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Phase 4
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Countries of recruitment
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Canada
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients will be eligible to participate if they have a diagnosis of CD, are between
8-18 years of age, and have been in remission for at least 4 weeks as indicated by a
PCDAI <10.
Exclusion Criteria:
- Patients will be ineligible if they have active disease with a PCDAI > 10, taking
corticosteroids, or taking more than 400 IU Vitamin D at enrollment.
Age minimum:
8 Years
Age maximum:
18 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Vitamin D Deficiency
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Intervention(s)
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Dietary Supplement: Vitamin D
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Primary Outcome(s)
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The proportion of pediatric CD patients achieving optimal 25OHD concentration
[Time Frame: 6 months]
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Secondary Outcome(s)
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If patients receiving 2000 IU Vitamin D are more likely to have remained in remission
[Time Frame: 6 months]
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Secondary ID(s)
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H10-01391
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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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