학술논문
High-Dose Vitamin D Does Not Prevent Postoperative Recurrence of Crohn's Disease in a Randomized Placebo-Controlled Trial.
Document Type
Academic Journal
Author
de Bruyn JR; Department of Gastroenterology and Hepatology.; Bossuyt P; Department of Gastroenterology and Hepatology, Imeldaziekenhuis Bonheiden, Bonheiden, Belgium.; Ferrante M; Department of Gastroenterology and Hepatology.; West RL; Department of Gastroenterology and Hepatology, Franciscus Gasthuis and Vlietland, Rotterdam, The Netherlands.; Dijkstra G; Department of Gastroenterology and Hepatology, University Medical Center Groningen, Groningen, The Netherlands.; Witteman BJ; Department of Gastroenterology and Hepatology, Gelderse Vallei Hospital, Ede, The Netherlands.; Wildenberg M; Department of Gastroenterology and Hepatology.; Hoentjen F; Department of Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, The Netherlands.; Franchimont D; Department of Gastroenterology and Hepatology, Erasme Hospital, Brussels, Belgium.; Clasquin E; Department of Gastroenterology and Hepatology.; van der Bilt JD; Department of Surgery, Flevoziekenhuis, Almere, The Netherlands.; Tollens T; Department of General and Abdominal Surgery, Imelda Hospital, Bonheiden, Belgium.; Bemelman WA; Department of Surgery, Amsterdam Inflammatory Bowel Disease Center, Amsterdam Gastroenterology and Metabolism, Amsterdam University Medical Center, University of Amsterdam, Amsterdam, The Netherlands.; D'Hoore A; Department of Abdominal Surgery, University Hospitals Leuven, KU Leuven, Leuven, Belgium.; Duijvestein M; Department of Gastroenterology and Hepatology.; D'Haens GR; Department of Gastroenterology and Hepatology. Electronic address: g.dhaens@amsterdamumc.nl.
Source
Publisher: W.B. Saunders for the American Gastroenterological Association Country of Publication: United States NLM ID: 101160775 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1542-7714 (Electronic) Linking ISSN: 15423565 NLM ISO Abbreviation: Clin Gastroenterol Hepatol Subsets: MEDLINE
Subject
Language
English
Abstract
Background & Aims: Vitamin D deficiency is common in Crohn's disease (CD). High-dose vitamin D had anti-inflammatory effects in preclinical studies and trials of patients with CD. We performed a randomized trial to determine whether high-dose vitamin D prevents postoperative recurrence of CD after ileocolonic resection.
Methods: Patients with CD after ileocolonic resection with ileocolonic anastomosis were assigned randomly to groups given weekly 25,000 IU oral vitamin D (n = 72) or placebo (n = 71) for 26 weeks, at 17 hospitals in The Netherlands and Belgium, from February 2014 through June 2017. Patients were assessed at baseline and at weeks 2, 6, 12, and 26 for laboratory and clinical parameters, and underwent ileocolonoscopy at 26 weeks. The primary end point was endoscopic recurrence (modified Rutgeerts score, ≥i2b, as assessed by blinded readers) at 26 weeks. Secondary end points included clinical recurrence (Crohn's disease activity index, ≥220), quality of life (measured by the 36-Item Short Form Health Survey, Inflammatory Bowel Disease Questionnaire, and EuroQol, a 5-dimension questionnaire), and outcomes associated with the baseline serum concentration of vitamin D.
Results: In the vitamin D group, serum levels of 25-hydroxy vitamin D increased from a median of 42 nmol/L at baseline to 81 nmol/L at week 26 (P < .00001), whereas levels did not change significantly in the placebo group and remained unchanged at 43 nmol/L. In the intention-to-treat analysis, the proportion of patients with endoscopic recurrence at 26 weeks did not differ significantly between the vitamin D vs the placebo group (58% vs 66%; P = .37). The cumulative rate of clinical recurrence did not differ significantly between the groups (18.1% in the vitamin D group vs 18.3% in the placebo group; P = .91). Quality of life improved slightly over time in both groups, but did not differ significantly between groups (P = .07). There were few adverse events in either group.
Conclusions: High-dose vitamin D, compared with placebo, did not reduce the incidence of postoperative endoscopic or clinical recurrence of CD in patients who underwent ileocolonic resection with ileocolonic anastomosis. ClinicalTrials.gov no: NCT02010762.
(Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)
Methods: Patients with CD after ileocolonic resection with ileocolonic anastomosis were assigned randomly to groups given weekly 25,000 IU oral vitamin D (n = 72) or placebo (n = 71) for 26 weeks, at 17 hospitals in The Netherlands and Belgium, from February 2014 through June 2017. Patients were assessed at baseline and at weeks 2, 6, 12, and 26 for laboratory and clinical parameters, and underwent ileocolonoscopy at 26 weeks. The primary end point was endoscopic recurrence (modified Rutgeerts score, ≥i2b, as assessed by blinded readers) at 26 weeks. Secondary end points included clinical recurrence (Crohn's disease activity index, ≥220), quality of life (measured by the 36-Item Short Form Health Survey, Inflammatory Bowel Disease Questionnaire, and EuroQol, a 5-dimension questionnaire), and outcomes associated with the baseline serum concentration of vitamin D.
Results: In the vitamin D group, serum levels of 25-hydroxy vitamin D increased from a median of 42 nmol/L at baseline to 81 nmol/L at week 26 (P < .00001), whereas levels did not change significantly in the placebo group and remained unchanged at 43 nmol/L. In the intention-to-treat analysis, the proportion of patients with endoscopic recurrence at 26 weeks did not differ significantly between the vitamin D vs the placebo group (58% vs 66%; P = .37). The cumulative rate of clinical recurrence did not differ significantly between the groups (18.1% in the vitamin D group vs 18.3% in the placebo group; P = .91). Quality of life improved slightly over time in both groups, but did not differ significantly between groups (P = .07). There were few adverse events in either group.
Conclusions: High-dose vitamin D, compared with placebo, did not reduce the incidence of postoperative endoscopic or clinical recurrence of CD in patients who underwent ileocolonic resection with ileocolonic anastomosis. ClinicalTrials.gov no: NCT02010762.
(Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)