Summary
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.
Conditions
IBD, Ulcerative Colitis, Crohn Disease
Recruitment Status
Active, not recruiting
Detailed Description
Study subjects will receiving 50,000 units of Vitamin D3 if they receive Remicade infusions every 4-6 weeks. Study subjects will receiving 100,000 units of Vitamin D3 if they receive Remicade infusions every 6-8 weeks.
Eligibility Criteria
Inclusion Criteria:
Existing diagnosis of IBD
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
Exclusion Criteria:
Pregnant Women
History of underlying kidney disease
History of granulomatous disease
Inability to take oral Vitamin D
History of hypercalcemia or hypercalciuria
Currently taking an anti-epileptic medication
History of pre-existing liver disease (excluding primary sclerosing cholangitis, non-alcoholic fatty liver disease, or steatohepatitis)
Intervention
Intervention Type
Intervention Name
Drug
Vitamin D3
Phase
Phase 3
Gender
All
Min Age
7 Years
Max Age
25 Years
Download Date
October 10, 2023
Principal Investigator
Web
Primary Contact Information
For more information on this trial, visit clinicaltrials.gov.
Contact
For more information and to contact the study team: