Efficacy and Safety of High‐dose Cholecalciferol in Patients With Inflammatory Bowel Disease Receiving Infliximab

Abstract

Objective:Vitamin D deficiency is prevalent in patients with inflammatory bowel disease (IBD). The goal of this study was to assess the efficacy and safety of high-dose, interval cholecalciferol administration in patients with IBD receiving infliximab.Methods:This prospective, longitudinal, open-label study enrolled pediatric and young adult patients with IBD and vitamin D deficiency. Subjects received 50,000 IU every 4 to 5 weeks (n = 11) or 100,000 IU every 6 to 8 weeks (n = 32) of oral cholecalciferol for 1 year. Dosing was directly observed and administered in conjunction with infliximab infusions. The primary endpoint was vitamin D sufficiency, defined as a 25-hydroxy-vitamin D (25-OHD) level ≥30 ng/mL.Results:Forty-three participants constituted the primary analysis population. 25-OHD levels reached steady-state after the third dose, and mean increases in 25-OHD levels were 8 vs. 4.5 ng/mL in the 100,000 IU vs. 50,000 IU treatment groups, respectively. Only 43.8% of patients receiving 100,000 IU and 18.2% of patients receiving 50,000 IU achieved sufficiency. There was no difference in the 25-OHD level responsiveness in patients with Crohn disease versus those with ulcerative colitis (P = 0.72). There was no correlation between 25-OHD levels and clinical disease activity in patients with Crohn disease (P = 0.85) or ulcerative colitis (P = 0.24).Conclusions:Supplementation with cholecalciferol was well-tolerated and direct observation is a promising paradigm for ensuring compliance with therapy. Patients with IBD, however, appear to require high doses of cholecalciferol, with less than half of patients (37% overall) achieving vitamin D sufficiency. Additional studies are necessary to determine the optimal treatment regimens.

Vitamin D in children with inflammatory bowel disease

“…Autoři se domnívají, že pacienti s IBD budou zřejmě vyžadovat vyšší dávkování vitaminem D než běžná populace. (31) S přibývajícími studiemi zabývajícími se efektem substituce vitaminu D na průběh IBD množství odlišných závěrů bohužel narůstá. Loňská velká metaanalýza hodnotící 22 randomizovaných klinických studií, která zahrnula 1874 jedinců, neprokázala, že by substituce vitaminem D ovlivňovala klinickou odpověď pacientů na léčbu IBD nebo riziko relapsu onemocnění.…”

The Role of Vitamin D in Patients with Inflammatory Bowel Disease Treated with Vedolizumab

“…Indeed, previous studies have shown that low vitamin D levels are associated with disease severity and vedolizumab failure in patients with IBD [13][14][15]. Additionally, despite high doses of vitamin D, patients can achieve sufficiency even with supplementation [16,17]. We previously described, in a small group of patients, a lack of clinical remission when vitamin D levels are less than 30 ng/mL and persistent elevation in C-reactive protein (CRP) when vitamin D levels are extremely low (<15 ng/mL) [18].…”