title: Impact of High-Dose Vitamin D3 Supplementation in Patients with Crohn's Disease in Remission: A Pilot Randomized Double-Blind Controlled Study.
abstract: To assess the tolerability and efficacy of high-dose vitamin D3 in patients with Crohn's disease (CD).
  
  
  
  This was a randomized, double-blind placebo-controlled trial of high-dose vitamin D3 at 10,000 IU daily (n = 18) compared to 1000 IU daily (n = 16) for 12 months in patients with CD in remission. The primary outcome was change in serum 25-hydroxy-vitamin D levels. Secondary outcomes included clinical relapse rates and changes in mood scores.
  
  
  
  High-dose vitamin D3 at 10,000 IU daily significantly improved 25-hydroxy-vitamin D levels from a mean of 73.5 nmol/L [standard deviation (SD) 11.7 nmol/L] to 160.8 nmol/L (SD 43.2 nmol/L) (p = 0.02). On an intention-to-treat basis, the rate of relapse was not significantly different between patients receiving low- and high-dose vitamin D3 (68.8 vs 33.3%, p = 0.0844). In per-protocol analysis, clinical relapse of Crohn's disease was less frequently observed in patients receiving a high dose (0/12 or 0%) compared to those receiving a low dose of 1000 IU daily (3/8 or 37.5%) (p = 0.049). Improvement in anxiety and depression scores and a good safety profile were observed in both groups treated with vitamin D3.
  
  
  
  Oral supplementation with high-dose vitamin D3 at 10,000 IU daily significantly improved serum 25-hydroxy-vitamin D levels. Rates of clinical relapse were similar between both groups. Larger studies using high-dose vitamin D3 for treatment of inflammatory bowel diseases are warranted. CLINICALTRIALS.
  
  
  
  NCT02615288.
authors.affiliation: Division of Gastroenterology, Department of Medicine, Farncombe Family Digestive Health Research Institute, McMaster University, 1280 Main Street West, Unit 3V28, Hamilton, ON, L8S 4K1, Canada. Neeraj.narula@medportal.ca.
authors.forename: Neeraj
authors.identifier: 0000-0002-1536-8436
authors.initials: N
authors.lastname: Narula
authors.affiliation: Division of Gastroenterology, Department of Medicine, Farncombe Family Digestive Health Research Institute, McMaster University, 1280 Main Street West, Unit 3V28, Hamilton, ON, L8S 4K1, Canada.
authors.forename: Mohan
authors.initials: M
authors.lastname: Cooray
authors.affiliation: Division of Gastroenterology, Department of Medicine, Farncombe Family Digestive Health Research Institute, McMaster University, 1280 Main Street West, Unit 3V28, Hamilton, ON, L8S 4K1, Canada.
authors.forename: Rebecca
authors.initials: R
authors.lastname: Anglin
authors.affiliation: Division of Gastroenterology, Department of Medicine, Farncombe Family Digestive Health Research Institute, McMaster University, 1280 Main Street West, Unit 3V28, Hamilton, ON, L8S 4K1, Canada.
authors.forename: Zack
authors.initials: Z
authors.lastname: Muqtadir
authors.affiliation: Division of Gastroenterology, Department of Medicine, Farncombe Family Digestive Health Research Institute, McMaster University, 1280 Main Street West, Unit 3V28, Hamilton, ON, L8S 4K1, Canada.
authors.forename: Alisha
authors.initials: A
authors.lastname: Narula
authors.affiliation: Division of Gastroenterology, Department of Medicine, Farncombe Family Digestive Health Research Institute, McMaster University, 1280 Main Street West, Unit 3V28, Hamilton, ON, L8S 4K1, Canada.
authors.forename: John K
authors.initials: JK
authors.lastname: Marshall
mesh_terms: D000328:Adult; D000339:Affect; D002762:Cholecalciferol / Q000008:administration & dosage*; D003424:Crohn Disease / Q000097:blood / Q000188:drug therapy* / Q000503:physiopathology / Q000523:psychology; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D010865:Pilot Projects; D012008:Recurrence; D014807:Vitamin D / Q000031:analogs & derivatives / Q000097:blood; D014815:Vitamins / Q000008:administration & dosage*
chemical_list: D014815:Vitamins; D014807:Vitamin D; D002762:Cholecalciferol; C104450:25-hydroxyvitamin D
keywords: Crohn’s disease; Inflammatory bowel disease; Ulcerative colitis; Vitamin D