Efficacy and Safety of Titrated High-Dose Cholecalciferol Supplementation in Children and Young Adult Patients with Inflammatory Bowel Disease.

Abstract

To assess the safety and efficacy of high-dose, oral cholecalciferol supplementation in children and young adults with inflammatory bowel disease treated with infliximab or vedolizumab. This was a prospective, longitudinal (1 year), open-label study of directly observed high-dose oral cholecalciferol administered every 4-8 weeks. Participants received either 100 000 IU every 4-6 weeks or 200 000 IU every 6-8 weeks, depending on the participant's infusion schedule. Dosing was titrated to a goal 25-hydroxyvitamin D (25-OHD) trough level of 40-60 ng/mL. Safety was assessed by spot urinary calcium and creatinine, and serum calcium levels. Participants' serum 25-OHD levels increased by a mean of 18.1 ng/mL (P < .001). At study conclusion, 58% (P < .001) and 91% (P < .001) of participants had 25-OHD levels greater than 40 ng/mL and 30 ng/mL, respectively. The response to cholecalciferol did not differ between patients with Crohn's disease or ulcerative colitis (P = .74). No adverse effects were observed, including changes in serum or urinary calcium levels. Mean spot urinary calcium to creatinine ratio 0.10 at baseline and 0.09 at study conclusion (P = .26). High-dose, intermittent cholecalciferol is a safe and effective approach to achieving and maintaining adequate 25-OHD in young patients with inflammatory bowel disease. https://clinicaltrials.gov/study/NCT04331639.