Vitamin D in Pediatric Crohn's Disease
1 other identifier
interventional
87
1 country
2
Brief Summary
Background: Crohn's disease (CD), a type of Inflammatory Bowel Disease (IBD), is a chronic relapsing inflammatory disorder of the digestive system. CD affects \~112,000 individuals in Canada, of whom 20-25% are diagnosed in childhood or adolescence. The specific cause of CD remains unknown; however, it is hypothesized that CD involves a complex interaction of several factors, including a genetically susceptible host, the intestinal mucosal immune system and microbe population. Several dietary factors have been explored for their potential role in the etiology of CD. However, no consensus on the role of diet has emerged. Recent evidence suggests a plausible link between a lack of Vitamin D and CD. Purpose \& Hypothesis: The investigators primary hypothesis is that a greater proportion of pediatric CD patients will achieve optimal 25OHD concentration (\> 75 nmol/L) on 2000 IU/d than 400 IU/d Vitamin D. Methods: Pediatric Crohn's Disease patients between 8-18 years of age, and have been in remission for at least 4 weeks as indicated by a Pediatric Crohn's Disease Activity Index (PCDAI) \<10 will be recruited for a double-blind, randomized, controlled trial where they will receive one of two dosages of vitamin D (10 or 50 ug/day) and will be asked to continue the supplementation for 6 months. Vitamin D levels will be measured in blood at baseline, 3 months, and 6 months. Dietary vitamin D intake will be estimated using a food frequency and lifestyle questionnaire. Data will be analyzed using multiple regression analysis controlling for baseline values. Expected Results and Conclusions: It is expected that a greater proportion of children receiving the 50 ug/day vitamin D supplement will achieve a blood vitamin level \>75 nmol/L compared to children receiving 10 ug/day. This data will aid policy makers, parents/children and healthcare workers in recommending an appropriate vitamin D dosage for the pediatric crohn's population.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Sep 2010
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 20, 2010
CompletedFirst Posted
Study publicly available on registry
August 24, 2010
CompletedStudy Start
First participant enrolled
September 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedFebruary 14, 2012
February 1, 2012
1.4 years
August 20, 2010
February 10, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The proportion of pediatric CD patients achieving optimal 25OHD concentration
To determine whether the proportion of pediatric CD patients achieving 25OHD concentration \> 75 nmol/L different between groups.
6 months
Secondary Outcomes (1)
If patients receiving 2000 IU Vitamin D are more likely to have remained in remission
6 months
Study Arms (2)
10 ug/day
EXPERIMENTAL50 ug/day
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of British Columbialead
- McMaster Universitycollaborator
Study Sites (2)
BC Children's Hospital
Vancouver, British Columbia, V6H 3V4, Canada
McMaster University
Hamilton, Ontario, L8N 3Z5, Canada
Related Publications (1)
Wingate KE, Jacobson K, Issenman R, Carroll M, Barker C, Israel D, Brill H, Weiler H, Barr SI, Li W, Lyon MR, Green TJ. 25-Hydroxyvitamin D concentrations in children with Crohn's disease supplemented with either 2000 or 400 IU daily for 6 months: a randomized controlled study. J Pediatr. 2014 Apr;164(4):860-5. doi: 10.1016/j.jpeds.2013.11.071. Epub 2014 Jan 11.
PMID: 24423431DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 20, 2010
First Posted
August 24, 2010
Study Start
September 1, 2010
Primary Completion
February 1, 2012
Study Completion
February 1, 2012
Last Updated
February 14, 2012
Record last verified: 2012-02