High dose vitamin D for young patients with inflammatory bowel disease on biologic therapy
Official title: Implementation of High Dose Interval Vitamin D Supplementation in Patients With Inflammatory Bowel Disease Receiving Infliximab or Vedolizumab
Run by Boston Children's Hospital · NCT04331639 · Data updated 2026-11-12
This study is testing if giving high doses of vitamin D to young people with inflammatory bowel disease who are on biologic treatments can improve their bone health and reduce inflammation.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 5 Years to 25 Years |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Boston Children's Hospital Academic / other |
| Drugs / interventions | Infliximab, Vedolizumab |
| Locations | 1 site (Boston, Massachusetts) |
| Status | Recruiting |
| Started | November 1, 2020 |
| Main results expected | September 1, 2024 |
| Study ends | December 31, 2025 |
| Registry record updated | March 3, 2025 |
| Trial ID | NCT04331639 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children and young adults aged 5-25 with a diagnosis of IBD who have low vitamin D levels and are receiving specific biologic therapies.
✕Probably not a fit
Patients with underlying kidney or liver diseases, or those unable to take oral vitamin D3, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study administers high dose interval vitamin D3 to young patients with inflammatory bowel disease (IBD) who are receiving biologic therapy, such as Infliximab or Vedolizumab. Participants will receive vitamin D3 every 4-8 weeks alongside their regular treatment, and researchers will collect blood samples and questionnaires to evaluate the effects on bone health and inflammation. The study aims to understand how vitamin D supplementation impacts IBD symptoms and overall health in this population.
Why it matters
Potential benefit: If successful, this approach could improve bone health and reduce inflammation in young patients with inflammatory bowel disease.
How similar studies have gone: While there is ongoing research into vitamin D supplementation in various conditions, this specific approach in the context of IBD and biologic therapy is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Boston Children's Hospital
Boston, Massachusetts, United States Recruiting
Study contacts
- Principal investigator: Rebecca Gordon, MD — Boston Children's Hospital
- Study coordinator: Rebecca Gordon, MD
- Email: rebecca.gordon@childrens.harvard.edu
- Phone: 617-355-7476
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.