High Dose Interval Vitamin D Supplementation in Patients With Inflammatory Bowel Disease R
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.
| Condition(s) | Inflammatory Bowel Disease, Crohn Disease, Ulcerative Colitis, Vitamin D Deficiency |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | 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 can participate | 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 |
| Ages | 5 Years to 25 Years |
| Sex | All |
| Lead sponsor | Boston Children's Hospital |
| Locations | Boston, Massachusetts, United States |
| Start date | 2020-11-01 |
| NCT ID | NCT04331639 |
| Official listing | https://clinicaltrials.gov/study/NCT04331639 |