Status:
TERMINATED
Vitamin D Levels in Children With IBD
Lead Sponsor:
Boston Children's Hospital
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Crohn's and Colitis Foundation
Conditions:
Inflammatory Bowel Disease
Crohn's Disease
Eligibility:
All Genders
5-21 years
Phase:
NA
Brief Summary
Research has shown that children with Inflammatory Bowel Disease may have lower levels of vitamin D than healthy children, especially in the winter. Vitamin D is important for growing and maintaining ...
Detailed Description
Vitamin D is essential for bone mineralization. The prevalence of vitamin D insufficiency \[serum 25-hydroxy-vitamin D concentration (25OHD) ≤ 20 ng/mL\] is high among adults with inflammatory bowel d...
Eligibility Criteria
Inclusion
- Clinical diagnosis of inflammatory bowel disease
- serum 25OHD level ≤ 20 ng/mL (Treatment Trial)
- serum 25OHD level \> 20 ng/mL (Maintenance Trial)
Exclusion
- Patients unable to take medications by mouth, pregnant, with liver/kidney failure, receiving anticonvulsant medications (specifically, phenobarbital, carbamazepine and phenytoin, since they lead to increased vitamin D metabolism through hepatic induction of the cytochrome P450 (CYP450) hydroxylase enzymes), regularly attending a tanning salon (once weekly or more), currently being treated for hypovitaminosis D with therapeutic doses of vitamin D (\> 800 IU per day) and unwilling to discontinue this regimen.
- patients on growth hormone, anabolic steroid hormones, calcitonin, bisphosphonates (Maintenance Trial only)
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
134 Patients enrolled
Trial Details
Trial ID
NCT00621257
Start Date
January 1 2008
End Date
March 1 2011
Last Update
March 22 2017
Active Locations (1)
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1
Children's Hospital, Boston
Boston, Massachusetts, United States, 02115