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RECRUITINGOBSERVATIONAL

High Dose Interval Vitamin D Supplementation in Patients With Inflammatory Bowel Disease Receiving Biologic Therapy

Implementation of High Dose Interval Vitamin D Supplementation in Patients With Inflammatory Bowel Disease Receiving Infliximab or Vedolizumab

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DIETARY_SUPPLEMENT

vitamin D3

Subjects 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.

Locations (1)

Boston Children's Hospital
Boston, Massachusetts, United States