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.
IBD, Ulcerative Colitis, Crohn Disease
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.
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
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)
December 4, 2020
Primary Contact Information
For more information on this trial, visit clinicaltrials.gov.
For more information and to contact the study team: