High Dose Interval Vitamin D Supplementation in Patients With Inflammatory Bowel Disease Receiving Biologic Therapy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age5-25
SponsorBoston Children's Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
History of any underlying kidney disease
History of preexisting liver disease
History of granulomatous disease
Inability to take oral vitamin D3 as a pill
Trial design
Treatments tested in this trial
- vitamin D3
Treatment groups
No treatment groups listed
Sponsors and collaborators
Source ClinicalTrials.gov