Vitamin D3 for Inflammatory Bowel Disease (IBD)
Recruiting in Palo Alto (17 mi)
Age: < 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Boston Children's Hospital
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 6 Jurisdictions
Trial Summary
What is the purpose of this trial?The goal of this study will be to assess the safety and efficacy of high-dose interval Vitamin D3 therapy in children and young adults with Inflammatory Bowel Disease being treated with serial Remicade infusions.
Eligibility Criteria
Inclusion Criteria
Age 0-25 years
Measured serum level of 25-OH Vitamin D of 15-29 ng/ml in the last 8 weeks and no changes in Vitamin D supplementation in the interim
You have been diagnosed with inflammatory bowel disease (IBD).
Exclusion Criteria
History of granulomatous disease
History of hypercalcemia or hypercalciuria
History of pre-existing liver disease (excluding primary sclerosing cholangitis, non-alcoholic fatty liver disease, or steatohepatitis)
+4 more
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Vitamin D3 TreatmentExperimental Treatment1 Intervention
Subjects receiving Remicade will be treated with oral Vitamin D3
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Boston Children's HospitalBoston, MA
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Who Is Running the Clinical Trial?
Boston Children's HospitalLead Sponsor