Vitamin D in Pediatric Crohn's Disease
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Prevention
|Official Title:||Vitamin D in Pediatric Crohn's Disease|
- The proportion of pediatric CD patients achieving optimal 25OHD concentration [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]To determine whether the proportion of pediatric CD patients achieving 25OHD concentration > 75 nmol/L different between groups.
- If patients receiving 2000 IU Vitamin D are more likely to have remained in remission [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]To determine if patients receiving 2000 IU Vitamin D are more likely to have remained in remission [Pediatric Crohn's Disease Activity Index (PCDAI) < 20] than those receiving 400 IU/d.
|Study Start Date:||September 2010|
|Study Completion Date:||February 2012|
|Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
|Experimental: 10 ug/day||
Dietary Supplement: Vitamin D
10 ug/day Vitamin D, taken for 6 months.
|Experimental: 50 ug/day||
Dietary Supplement: Vitamin D
50 ug/day Vitamin D, taken for 6 months.
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01187459
|Canada, British Columbia|
|BC Children's Hospital|
|Vancouver, British Columbia, Canada, V6H 3V4|
|Hamilton, Ontario, Canada, L8N 3Z5|