title: Efficacy and safety of a short course of very-high-dose cholecalciferol in hemodialysis.
abstract: BACKGROUND
  Vitamin D deficiency is highly prevalent among hemodialysis patients, but little data exist in support of an optimal repletion regimen.
  
  
  OBJECTIVE
  The objective was to ascertain the efficacy of weekly very-high-dose cholecalciferol (vitamin D(3)) in correcting vitamin D insufficiency and deficiency in patients with stage 5D chronic kidney disease.
  
  
  METHODS
  We conducted a prospective, double-blind, randomized controlled pilot study that compared placebo with very high doses of oral cholecalciferol for 3 wk (200,000 IU/wk) in hemodialysis patients. We examined the rate of correction of vitamin D insufficiency or deficiency and the effect of treatment on markers of mineral metabolism and routine laboratory variables.
  
  
  RESULTS
  Twenty-seven subjects received placebo, and 25 received cholecalciferol. The majority (94%) of subjects had serum 25-hydroxyvitamin D [25(OH)D] concentrations <30 ng/mL. Study groups were similar with respect to baseline clinical characteristics, with the exception of hemoglobin concentrations, which were lower in the cholecalciferol-treated group (P < 0.04). At follow-up, 90.5% of subjects treated with cholecalciferol achieved serum 25(OH)D concentrations ≥30 ng/mL in contrast to 13.6% of the placebo group. There were no significant changes in serum calcium, phosphate, or intact parathyroid hormone during the study.
  
  
  CONCLUSIONS
  Short-term, high-dose oral cholecalciferol treatment of vitamin D deficiency in hemodialysis patients appears to be effective and with no evidence of toxic effects. This trial was registered at clinicaltrials.gov as NCT00912782.
authors.affiliation: Division of Nephrology, Emory University, Atlanta, GA, USA. hwasse@emory.edu
authors.forename: Haimanot
authors.initials: H
authors.lastname: Wasse
authors.forename: Rong
authors.initials: R
authors.lastname: Huang
authors.forename: Qi
authors.initials: Q
authors.lastname: Long
authors.forename: Salman
authors.initials: S
authors.lastname: Singapuri
authors.forename: Paolo
authors.initials: P
authors.lastname: Raggi
authors.forename: Vin
authors.initials: V
authors.lastname: Tangpricha
mesh_terms: D000328:Adult; D000368:Aged; D002762:Cholecalciferol / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006454:Hemoglobins / Q000378:metabolism; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011446:Prospective Studies; D006435:Renal Dialysis / Q000009:adverse effects; D051436:Renal Insufficiency, Chronic / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D014807:Vitamin D / Q000031:analogs & derivatives / Q000097:blood; D014808:Vitamin D Deficiency / Q000097:blood / Q000188:drug therapy* / Q000209:etiology
chemical_list: D006454:Hemoglobins; D014807:Vitamin D; D002762:Cholecalciferol; C104450:25-hydroxyvitamin D