title: A randomized trial of cholecalciferol versus doxercalciferol for lowering parathyroid hormone in chronic kidney disease.
abstract: OBJECTIVE
  The optimal treatment of secondary hyperparathyroidism in chronic kidney disease (CKD) is unknown.
  
  
  METHODS
  We conducted a randomized, blinded, 3-month trial in vitamin D-deficient CKD stage 3 and 4 patients with parathyroid hormone (PTH) values above the Kidney Disease Outcomes Quality Initiative target, comparing cholecalciferol (4000 IU/d x 1 month, then 2000 IU/d; n = 22) to doxercalciferol (1 microg/d; n = 25).
  
  
  RESULTS
  There was no difference in baseline demographics or lab tests, except a slightly higher estimated GFR (eGFR) in the doxercalciferol group. There was a significant increase in vitamin D level in the cholecalciferol group (14 +/- 6 to 37 +/- 10 ng/ml; P < 0.001) but no change in the doxercalciferol group. The PTH decreased by 27% +/- 34% in the doxercalciferol group (P = 0.002) and decreased by 10% +/- 31% in the cholecalciferol group (P = 0.16), but the difference between treatments was NS (P = 0.11). Similar results were found when absolute PTH change from baseline to end point was analyzed in a repeated-measures ANOVA model. The serum calcium and urine calcium excretions were not different. Additional non-mineral-related end points, albuminuria, and BP were evaluated, and although trends were present, this did not reach significance.
  
  
  CONCLUSIONS
  This prospective, randomized trial demonstrated a within-group reduction in PTH in the doxercalciferol-treated patients but no significant difference between the doxercalciferol and cholecalciferol patients. Larger, long-term studies are needed to demonstrate efficacy of mineral-related and non-mineral-related end points and safety.
authors.affiliation: Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana 46202, USA. smoe@iupui.edu
authors.forename: Sharon M
authors.initials: SM
authors.lastname: Moe
authors.forename: Akber
authors.initials: A
authors.lastname: Saifullah
authors.forename: Robert E
authors.initials: RE
authors.lastname: LaClair
authors.forename: Sohail A
authors.initials: SA
authors.lastname: Usman
authors.forename: Zhangsheng
authors.initials: Z
authors.lastname: Yu
mesh_terms: D000368:Aged; D015415:Biomarkers / Q000097:blood / Q000652:urine; D002118:Calcium / Q000097:blood / Q000652:urine; D002762:Cholecalciferol / Q000009:adverse effects / Q000627:therapeutic use*; D002908:Chronic Disease; D004872:Ergocalciferols / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D006962:Hyperparathyroidism, Secondary / Q000097:blood / Q000188:drug therapy* / Q000209:etiology; D007674:Kidney Diseases / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010281:Parathyroid Hormone / Q000097:blood*; D011446:Prospective Studies; D016037:Single-Blind Method; D013997:Time Factors; D016896:Treatment Outcome; D014807:Vitamin D / Q000097:blood; D014808:Vitamin D Deficiency / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D014815:Vitamins / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D015415:Biomarkers; D004872:Ergocalciferols; C470125:PTH protein, human; D010281:Parathyroid Hormone; D014815:Vitamins; D014807:Vitamin D; D002762:Cholecalciferol; C042533:1 alpha-hydroxyergocalciferol; D002118:Calcium