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Vitamin D in Pediatric Crohn's Disease

This study has been completed.
Sponsor:
Collaborator:
McMaster University
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01187459
First received: August 20, 2010
Last updated: February 10, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Vitamin D Deficiency
Dietary Supplement: Vitamin D
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 87
Study Start Date: September 2010
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   8 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01187459

Locations
Canada, British Columbia
BC Children's Hospital
Vancouver, British Columbia, Canada, V6H 3V4
Canada, Ontario
McMaster University
Hamilton, Ontario, Canada, L8N 3Z5
Sponsors and Collaborators
University of British Columbia
McMaster University
  More Information

No publications provided by University of British Columbia

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01187459     History of Changes
Other Study ID Numbers: H10-01391
Study First Received: August 20, 2010
Last Updated: February 10, 2012
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Vitamin D
Crohn's Disease
Dose Response

Additional relevant MeSH terms:
Crohn Disease
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases
Malnutrition
Nutrition Disorders
Ergocalciferols
Vitamin D
Vitamins
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 24, 2014