HIGH-DOSE VITAMIN D DOES NOT PREVENT POSTOPERATIVE RECURRENCE OF CROHN'S DISEASE IN A RANDOMIZED PLACEBO-CONTROLLED TRIAL.

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 following ileocolonic resection with ileocolonic anastomosis were randomly assigned 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 week 2, 6, 12, and 26 for laboratory and clinical parameters, and underwent ileocolonoscopy at 26 weeks. The primary endpoint was endoscopic recurrence (modified Rutgeerts score ≥i2b, assessed by blinded readers) at 26 weeks. Secondary endpoints included clinical recurrence (Crohn’s disease activity index ≥ 220), quality of life (measured by SF-36, IBD-Q and EQ-5D) and outcomes associated with baseline serum concentration of vitamin D. Results In the vitamin D group, serum levels of 25-hydroxy vitamin D increased from median 42 nmol/L at baseline to 81 nmol/L at week 26 (P 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.