High Dose Vitamin D for IBD Patients on Biologic Therapy

This observational study is looking at how giving high doses of vitamin D3 affects young people (ages 5-25) with inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis. You could be eligible if you are already receiving biologic treatments like Infliximab or Vedolizumab every 4-8 weeks and have low vitamin D levels (less than 40 ng/mL). The researchers will give you oral high-dose vitamin D3 at the same time as your biologic treatment. The main goal is to see if participants reach a target vitamin D level by the end of the study, which could be up to 64 weeks. The current status of this study is unclear, and it plans to enroll 50 participants.

Study design
This is an observational study with a planned enrollment of 50 participants. It is not specified if it is randomized or blinded.
What's involved
You will receive oral high-dose vitamin D3 concurrently with your regular biologic treatment every 4-8 weeks. Additional bloodwork and questionnaires will be collected during your infusion visits.
Compensation
Not stated in the trial record.
Follow-up
Your vitamin D levels will be measured at the study's conclusion, which can be up to 64 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04331639

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

Recruiting
Not specifiedAges 5–25Observational
Boston Children's Hospital
~50 participants
Updated 2025-03-03 on ClinicalTrials.gov
What's tested:vitamin D3

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
vitamin D target
Measured over at study conclusion, up to 64 weeks
Inflammatory Bowel Disease
Crohn Disease
Ulcerative Colitis
Vitamin D Deficiency
1 sites across 1 states
Massachusetts1
  • Rebecca Gordon, MD · PRINCIPAL_INVESTIGATOR · Boston Children's Hospital

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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
  • vitamin D targetat study conclusion, up to 64 weeks

    assessment of the percentage of patients achieving a serum 25-OHD level in the range of 40-60 ng/mL