NCT04331639Recruiting
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
Source: ClinicalTrials.gov · Last updated 3 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 50 (estimated)
- First submitted
- 23 Mar 2020
- Start date
- 1 Nov 2020
- Primary completion date
- 1 Sept 2024
- Lead sponsor
- Boston Children's Hospital
- Diseases
- Crohn's disease, Ulcerative colitis
- NCT number
- NCT04331639
What you commit to
- Study type: Observational
- Planned participants: 50
- From 1 Nov 2020 to the primary completion date, 1 Sept 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently, or within the past 3 months, taking an anti-epileptic medication or Lasix
Other illness
- History of any underlying kidney disease
- History of preexisting liver disease
- History of granulomatous disease
- History of hypercalcemia or hypercalciuria
Other
- Inability to take oral vitamin D3 as a pill
Who the study is looking for
- 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
Age in the registry: 5 years to 25 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Boston Children's Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.