title: Nutritional vitamin D supplementation in dialysis: a randomized trial.
abstract: OBJECTIVE
  Vitamin D (25-hydroxyvitamin D; 25[OH]D) deficiency is common in patients initiating long-term hemodialysis, but the safety and efficacy of nutritional vitamin D supplementation in this population remain uncertain.
  
  
  METHODS
  This randomized, placebo-controlled, parallel-group multicenter trial compared two doses of ergocalciferol with placebo between October 2009 and March 2013. Hemodialysis patients (n=105) with 25(OH)D levels ≤32 ng/ml from 32 centers in the Northeast United States were randomly assigned to oral ergocalciferol, 50,000 IU weekly (n=36) or monthly (n=33), or placebo (n=36) for a 12-week treatment period. The primary endpoint was the achievement of vitamin D sufficiency (25[OH]D >32 ng/ml) at the end of the 12-week treatment period. Survival was assessed through 1 year.
  
  
  RESULTS
  Baseline characteristics were similar across all arms, with overall mean±SD 25(OH)D levels of 21.9±6.9 ng/ml. At 12 weeks, vitamin D sufficiency (25[OH]D >32 ng/ml) was achieved in 91% (weekly), 66% (monthly), and 35% (placebo) (P<0.001). Mean 25(OH)D was significantly higher in both the weekly (49.8±2.3 ng/ml; P<0.001) and monthly (38.3±2.4 ng/ml; P=0.001) arms compared with placebo (27.4±2.3 ng/ml). Calcium, phosphate, parathyroid hormone levels, and active vitamin D treatment did not differ between groups. All-cause and cause-specific hospitalizations and adverse events were similar between groups during the intervention period. Lower all-cause mortality among ergocalciferol-treated participants was not statistically significant (hazard ratio, 0.28; 95% confidence interval, 0.07 to 1.19).
  
  
  CONCLUSIONS
  Oral ergocalciferol can increase 25(OH)D levels in incident hemodialysis patients without significant alterations in blood calcium, phosphate, or parathyroid hormone during a 12-week period.
authors.affiliation: Division of Nephrology, Department of Medicine, ibhan@mgh.harvard.edu.
authors.forename: Ishir
authors.initials: I
authors.lastname: Bhan
authors.affiliation: Division of Nephrology, Department of Medicine.
authors.forename: Dorothy
authors.initials: D
authors.lastname: Dobens
authors.affiliation: Division of Nephrology, Department of Medicine.
authors.forename: Hector
authors.initials: H
authors.lastname: Tamez
authors.affiliation: Division of Nephrology, Department of Medicine.
authors.forename: Joseph J
authors.initials: JJ
authors.lastname: Deferio
authors.affiliation: Department of Medicine, Division of Biological Sciences, The University of Chicago, Chicago, Illinois.
authors.forename: Yan Chun
authors.initials: YC
authors.lastname: Li
authors.affiliation: Infectious Disease Unit, Departments of Pediatrics and Medicine, and.
authors.forename: H Shaw
authors.initials: HS
authors.lastname: Warren
authors.affiliation: Division of Nephrology, Department of Medicine.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Ankers
authors.affiliation: Division of Nephrology, Department of Medicine.
authors.forename: Julia
authors.initials: J
authors.lastname: Wenger
authors.affiliation: Division of Nephrology, Department of Medicine.
authors.forename: J Kevin
authors.initials: JK
authors.lastname: Tucker
authors.affiliation: Division of Nephrology, Department of Medicine.
authors.forename: Caitlin
authors.initials: C
authors.lastname: Trottier
authors.affiliation: Pharmacy Department, Massachusetts General Hospital, Boston, Massachusetts; and.
authors.forename: Fridosh
authors.initials: F
authors.lastname: Pathan
authors.affiliation: Division of Nephrology, Department of Medicine.
authors.forename: Sahir
authors.initials: S
authors.lastname: Kalim
authors.affiliation: Division of Nephrology, Department of Medicine.
authors.forename: Sagar U
authors.initials: SU
authors.lastname: Nigwekar
authors.affiliation: Division of Nephrology, Department of Medicine.
authors.forename: Ravi
authors.initials: R
authors.lastname: Thadhani
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D015415:Biomarkers / Q000097:blood; D002423:Cause of Death; D019587:Dietary Supplements / Q000009:adverse effects; D004311:Double-Blind Method; D004872:Ergocalciferols / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006760:Hospitalization; D006801:Humans; D007674:Kidney Diseases / Q000097:blood / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009511:New England; D009752:Nutritional Status; D006435:Renal Dialysis / Q000009:adverse effects / Q000401:mortality; D013997:Time Factors; D016896:Treatment Outcome; D014807:Vitamin D / Q000031:analogs & derivatives* / Q000097:blood; D014808:Vitamin D Deficiency / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality
chemical_list: D015415:Biomarkers; D004872:Ergocalciferols; D014807:Vitamin D; C104450:25-hydroxyvitamin D
keywords: ESRD; clinical trial; dialysis; vitamin D