title: Biochemical parameters after cholecalciferol repletion in hemodialysis: results From the VitaDial randomized trial.
abstract: BACKGROUND
  The 2009 KDIGO (Kidney Disease: Improving Global Outcomes) chronic kidney disease-mineral and bone disorder clinical practice guideline suggests correcting 25-hydroxyvitamin D3 (25[OH]D) levels<30ng/mL in patients treated with maintenance hemodialysis, but does not provide a specific treatment protocol.
  
  
  METHODS
  2-center, double-blind, randomized, 13-week, controlled trial followed by a 26-week open-label study.
  
  
  METHODS
  55 adult maintenance hemodialysis patients with 25(OH)D levels<30ng/mL were recruited from June 2008 through October 2009.
  
  
  METHODS
  Cholecalciferol, 25,000IU, per week orally versus placebo for 13 weeks, then 26 weeks of individualized cholecalciferol prescription based on NKF-KDOQI (National Kidney Foundation-Kidney Disease Outcomes Quality Initiative) guidelines.
  
  
  RESULTS
  Primary end point was the percentage of patients with 25(OH)D levels≥30ng/mL at 13 weeks. Secondary outcomes included the percentage of patients with normal calcium, phosphorus, and intact parathyroid hormone (iPTH) blood levels. Safety measures included incidence of hypercalcemia and hypervitaminosis D.
  
  
  METHODS
  Blood calcium and phosphate were measured weekly; iPTH, 25(OH)D, 1,25-dihydroxyvitamin D3 (1,25[OH]2D), and bone turnover markers, trimonthly; fetuin A and fibroblast growth factor 23 (FGF-23) serum levels and aortic calcification scores were determined at weeks 0 and 39.
  
  
  RESULTS
  The primary end point significantly increased in the treatment group compared with the placebo group (61.5% vs 7.4%; P<0.001), as well as 1,25(OH)2D levels (22.5 [IQR, 15-26] vs 11 [IQR, 10-15]pg/mL; P<0.001) and the proportion of patients achieving the target calcium level (76.9% vs 48.2%; P=0.03). Incidence of hypercalcemia and phosphate and iPTH levels were similar between groups. The second 26-week study phase did not significantly modify the prevalence of 25(OH)D level≥30ng/mL in patients issued from the placebo group.
  
  
  CONCLUSIONS
  Small size of the study population.
  
  
  CONCLUSIONS
  Oral weekly administration of 25,000IU of cholecalciferol for 13 weeks is an effective, safe, inexpensive, and manageable way to increase 25(OH)D and 1,25(OH)2D levels in hemodialysis patients. Further evaluation of clinical end points is suggested.
authors.affiliation: Nephrology Department, Erasme Hospital, Université Libre de Bruxelles, Brussels, Belgium. Electronic address: anmassar@ulb.ac.be.
authors.forename: Annick
authors.initials: A
authors.lastname: Massart
authors.affiliation: Nephrology Department, Centre Hospitalier Epicura, Baudour, Belgium.
authors.forename: Frédéric Daniel
authors.initials: FD
authors.lastname: Debelle
authors.affiliation: Ecole de Santé Publique, Erasme Hospital, Brussels, Belgium.
authors.forename: Judith
authors.initials: J
authors.lastname: Racapé
authors.affiliation: Clinical Biology Department, Erasme Hospital, Brussels, Belgium.
authors.forename: Christine
authors.initials: C
authors.lastname: Gervy
authors.affiliation: Laboratory of Experimental Nephrology, Faculty of Medicine, Université Libre de Bruxelles, Brussels, Belgium.
authors.forename: Cécile
authors.initials: C
authors.lastname: Husson
authors.affiliation: Nephrology Department, Centre Hospitalier Epicura, Baudour, Belgium.
authors.forename: Michel
authors.initials: M
authors.lastname: Dhaene
authors.affiliation: Nephrology Department, Universitair Ziekenhuis, Vrije Universiteit Brussel, Brussels, Belgium.
authors.forename: Karl Martin
authors.initials: KM
authors.lastname: Wissing
authors.affiliation: Nephrology Department, Erasme Hospital, Université Libre de Bruxelles, Brussels, Belgium.
authors.forename: Joëlle Louise
authors.initials: JL
authors.lastname: Nortier
mesh_terms: D000368:Aged; D002762:Cholecalciferol / Q000008:administration & dosage* / Q000097:blood*; D004311:Double-Blind Method; D005260:Female; D000089703:Fibroblast Growth Factor-23; D005500:Follow-Up Studies; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D006435:Renal Dialysis / Q000379:methods*; D051436:Renal Insufficiency, Chronic / Q000097:blood* / Q000628:therapy*; D014807:Vitamin D / Q000097:blood
chemical_list: C000717427:FGF23 protein, human; D014807:Vitamin D; D002762:Cholecalciferol; D000089703:Fibroblast Growth Factor-23
keywords: 1,25-dihydroxyvitamin D; 25-hydroxyvitamin D; Cholecalciferol; aortic calcification score; bone fracture; calcitriol; calcium; clinical practice guidelines; falls; fetuin A; fibroblast growth factor 23 (FGF-23); hemodialysis; nutritional vitamin D; parathyroid hormone (PTH); vascular calcification; vitamin D; vitamin D deficiency; vitamin D repletion