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
This trial does not accept healthy volunteersQualifiers
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 population
See above. Enrolling all eligible participants, who wish to participate, until reach enrollment target.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
vitamin D3
Dietary supplementSubjects will receive oral high dose interval vitamin D3, concurrently when they are receiving their biologic treatment for their inflammatory bowel disease every 4-8 weeks.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
vitamin D target
assessment of the percentage of patients achieving a serum 25-OHD level in the range of 40-60 ng/mL
Time frame
at study conclusion, up to 64 weeksSecondary outcomes
1
change in vitamin D level
assess change in serum 25-OHD level from study entry to study conclusion
Time frame
at study conclusion, up to 64 weeks2
vitamin D binding protein
assessing vitamin D binding protein and free vitamin D
Time frame
at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion)3
parathyroid hormone
assessing parathyroid hormone
Time frame
at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion)4
serum safety parameter
evaluate serum calcium level
Time frame
at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov