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High Dose Interval Vitamin D Supplementation in Patients With Inflammatory Bowel Disease Receiving Biologic Therapy
NCT04331639 · Boston Children's Hospital
In plain English
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Official title
Implementation of High Dose Interval Vitamin D Supplementation in Patients With Inflammatory Bowel Disease Receiving Infliximab or Vedolizumab
About this study
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 investigators will collect additional bloodwork when participants are getting clinical labwork in order to assess markers of bone health and inflammation in response to vitamin D treatment. The investigators will serially assess with questionnaires associated measures, including dietary vitamin D and calcium intake, sunlight exposure, physical activity, fracture history, IBD disease activity, and overall health.
Eligibility criteria
Inclusion Criteria:
* 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 Criteria:
* 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
Study design
Enrollment target: 50 participants
Age groups: child, adult
Timeline
Starts: 2020-11-01
Estimated completion: 2025-12-31
Last updated: 2025-03-03
Interventions
Dietary Supplement: vitamin D3
Primary outcomes
- • vitamin D target (at study conclusion, up to 64 weeks)
Sponsor
Boston Children's Hospital · other
Contacts & investigators
ContactRebecca Gordon, MD · contact · rebecca.gordon@childrens.harvard.edu · 617-355-7476
InvestigatorRebecca Gordon, MD · principal_investigator, Boston Children's Hospital
All locations (1)
Boston Children's HospitalRecruiting
Boston, Massachusetts, United States