Efficacy and Safety of High-dose Cholecalciferol in Patients With Inflammatory Bowel Disease Receiving Infliximab
Gordon RJ, Wells R, Johansen C, Liu S, Dahlberg SE, Snapper SB, Rufo PA
Journal of pediatric gastroenterology and nutrition · 5 citations
Review labels
Neutral facts our review recorded about how this study was done. They describe method, never whether we like the result.
How it was studied
- Design
- Cohort study (indexed by PubMed)
- Studied in
- People
- Main outcome
- Health markers and function
Who paid for it
- Funding
- Funding not disclosed
Publication
- Published
- 2022-01-18 · J Pediatr Gastroenterol Nutr · vol. 74 · issue 4 · pp. 476–483
- Publisher
- Lippincott Williams & Wilkins
- Cited
- 6 citations · more than 61% of similar papers · 0.6× the field average
- References
- 51 works
- Access
- Paywalled
- Research areas
- Vitamin D Research Studies · Inflammatory Bowel Disease · Clostridium difficile and Clostridium perfringens research
- Keywords
- Cholecalciferol, Inflammatory bowel disease, Infliximab, Vitamin D and neurology, Vitamin, vitamin D deficiency
- MeSH
- humans, colitis, ulcerative, inflammatory bowel diseases, crohn disease, vitamin d deficiency, chronic disease, cholecalciferol, vitamins, vitamin d, prospective studies, dietary supplements, child, young adult, infliximab
7 authors
From US
- Rebecca J. Gordon · corresponding
- Reeder Wells
- Camille Johansen
- Shanshan LiuBoston Children's Hospital
- Suzanne E. DahlbergBoston Children's Hospital
- Scott B. Snapper
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.
Abstract via Europe PMC. Copyright remains with the authors or publisher.
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