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 citas
Etiquetas de revisión
Financiación no declaradaDatos neutrales que nuestra revisión registró sobre cómo se hizo este estudio. Describen el método, nunca si nos gusta el resultado.
Cómo se estudió
- Diseño
- Estudio de cohortes (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación no declarada
Publicación
- Publicado
- 2022-01-18 · J Pediatr Gastroenterol Nutr · vol. 74 · número 4 · págs. 476–483
- Editorial
- Lippincott Williams & Wilkins
- Citado
- 6 citas · más que el 61% de estudios similares · 0.6× el promedio de su campo
- Referencias
- 51 trabajos
- Acceso
- De pago
- Áreas de investigación
- Vitamin D Research Studies · Inflammatory Bowel Disease · Clostridium difficile and Clostridium perfringens research
- Palabras clave
- 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 autores
- Rebecca J. Gordon · autor de correspondencia
- Reeder Wells
- Camille Johansen
- Shanshan Liu🇺🇸Boston Children's Hospital
- Suzanne E. Dahlberg🇺🇸Boston Children's Hospital
- Scott B. Snapper
- Paul A. Rufo
Resumen
El texto original del estudio, en el idioma en que se publicó.
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.
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