Status:
RECRUITING
High Dose Interval Vitamin D Supplementation in Patients With Inflammatory Bowel Disease Receiving Biologic Therapy
Lead Sponsor:
Boston Children's Hospital
Conditions:
Inflammatory Bowel Disease
Crohn Disease
Eligibility:
All Genders
5-25 years
Brief Summary
The investigators will be administering oral high dose interval vitamin D, concurrently when participants are receiving biologic therapy for their inflammatory bowel disease. The investigators will be...
Detailed Description
The investigators will be administering oral high dose interval vitamin D3 concurrently when participants with inflammatory bowel disease (IBD) are receiving biologic therapy every 4-8 weeks. The inve...
Eligibility Criteria
Inclusion
- Existing diagnosis of IBD, including Crohn disease, ulcerative colitis, and indeterminate colitis
- Receiving treatment with Infliximab or Vedolizumab every 4-8 weeks
- Age 5-25 years old, at study entry
- Measured serum level of 25-OHD of less than 40 ng/mL in the last 4-8 weeks and no changes in vitamin D supplementation in the interim. Of note, 25-OHD levels are evaluated routinely as part of standard clinical care for IBD
Exclusion
- History of any underlying kidney disease
- History of preexisting liver disease
- History of granulomatous disease
- Inability to take oral vitamin D3 as a pill
- History of hypercalcemia or hypercalciuria
- Currently, or within the past 3 months, taking an anti-epileptic medication or Lasix
Key Trial Info
Start Date :
November 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04331639
Start Date
November 1 2020
End Date
December 31 2025
Last Update
March 3 2025
Active Locations (1)
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1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115