Clinical Trial: Vitamin D in Pediatric Crohn's Disease
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Vitamin D in Pediatric Crohn's Disease
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.
Detailed Summary:
Trial Objectives: Our 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. Our primary objective is to determine whether the proportion of pediatric CD patients achieving 25OHD concentration > 75 nmol/L is greater in those receiving 2000 IU/d or 400 IU/d Vitamin D. Our secondary objective is 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 Design: This will be a parallel study design with two levels of Vitamin D: 400 IU/d, and 2000 IU/d supplement of Vitamin D3.
Study Duration: 6 Months
Number of Sites (inside and outside of Canada):
- Children's and Women's Hospital of British Columbia
- McMaster's Children's Hospital
List of Investigators:
- Tim Green, PhD. Faculty of Land and Food Systems, UBC
- Kevan Jacobson MD. Pediatric GI, UBC
- Robert Issenman MD. Pediatric GI, McMaster University
- Susan Barr PhD. Faculty of Land and Food Systems, UBC Sample Size: Forty-five subjects per group will allow us to detect as little as a 20% difference in the proportion of participants achieving a 25OHD >75 nmol/L between the two doses with 80% power and a one sided of 0.05. Assuming a 10% attrition rate we will need to recruit 50 subjects per group. Clinical experience indicates t
Sponsor: University of British Columbia
Current Primary Outcome: The proportion of pediatric CD patients achieving optimal 25OHD concentration [ Time Frame: 6 months ]
To determine whether the proportion of pediatric CD patients achieving 25OHD concentration > 75 nmol/L different between groups.
Original Primary Outcome: Same as current
Current Secondary Outcome: If patients receiving 2000 IU Vitamin D are more likely to have remained in remission [ Time Frame: 6 months ]
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.
Original Secondary Outcome: Same as current
Information By: University of British Columbia
Dates:
Date Received: August 20, 2010
Date Started: September 2010
Date Completion:
Last Updated: February 10, 2012
Last Verified: February 2012
