High Dose Interval Vitamin D Supplementation in Patients With Inflammatory Bowel Disease Receiving Biologic Therapy
Recruiting now
Conditions studied: Inflammatory Bowel Disease, Crohn Disease, Ulcerative Colitis, Vitamin D Deficiency
In brief
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 collecting some additional bloodwork and questionnaires at the time of participants infusions.
Key facts
- Study ID
- NCT04331639
- Run by
- Boston Children's Hospital
- People needed
- 50
- Starts
- 2020-11-01
- Expected to finish
- 2025-12-31
- Last updated by the study team
- 2025-03-03
Who can join
Age: 5 and older, up to 25. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Boston Children's Hospital — Boston, Massachusetts, United States (enrolling)
Full record on ClinicalTrials.gov
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