NCT04331639 High Dose Interval Vitamin D Supplementation in Patients With Inflammatory Bowel Disease Receiving Biologic Therapy
| NCT ID | NCT04331639 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Boston Children's Hospital |
| Condition | Inflammatory Bowel Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2020-11-01 |
| Primary Completion | 2024-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2020-11-01 with a primary completion date of 2024-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Rebecca Gordon, MD
PRINCIPAL INVESTIGATOR
Boston Children's Hospital
Frequently Asked Questions
Who can join the NCT04331639 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, up to 25 Years, studying Inflammatory Bowel Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04331639 currently recruiting?
Yes, NCT04331639 is actively recruiting participants. Contact the research team at rebecca.gordon@childrens.harvard.edu for enrollment information.
Where is the NCT04331639 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT04331639 clinical trial?
NCT04331639 is sponsored by Boston Children's Hospital. The principal investigator is Rebecca Gordon, MD at Boston Children's Hospital. The trial plans to enroll 50 participants.