title: Paricalcitol versus ergocalciferol for secondary hyperparathyroidism in CKD stages 3 and 4: a randomized controlled trial.
abstract: BACKGROUND
  The efficacy of 25-hydroxyvitamin D (25[OH]D) supplementation versus vitamin D receptor activators for the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) stages 3 or 4 and vitamin D deficiency is unclear.
  
  
  METHODS
  Randomized controlled trial.
  
  
  METHODS
  80 patients with CKD stages 3 or 4, 25(OH)D level <30 ng/mL, and SHPT in a single medical center.
  
  
  METHODS
  Ergocalciferol, 50,000 units, titrated to achieve serum levels ≥30 ng/mL versus paricalcitol, 1 or 2 μg/d, for 16 weeks.
  
  
  RESULTS
  The occurrence of 2 consecutive parathyroid hormone (PTH) levels decreased by at least 30% from baseline. All analyses were intention to treat.
  
  
  RESULTS
  Baseline characteristics in the 2 groups were similar. 21 patients (53%) on paricalcitol and 7 patients (18%) on ergocalciferol treatment achieved the primary outcome measure (P = 0.002). After 16 weeks, PTH levels did not decrease significantly in patients receiving ergocalciferol, but were decreased significantly in those treated with paricalcitol (mean estimate of between-group difference over 16 weeks of therapy, 43.9 pg/mL; 95% CI, 11.2-76.6; P = 0.009). Serum 25(OH)D levels increased significantly after 16 weeks in only the ergocalciferol group, but not the paricalcitol group (mean estimate of between-group difference over 16 weeks of therapy, 7.08 ng/mL; 95% CI, 4.32-9.85; P < 0.001). Episodes of hyperphosphatemia and hypercalcemia were not significantly different between the 2 groups.
  
  
  CONCLUSIONS
  Lack of blinding and use of surrogate end points.
  
  
  CONCLUSIONS
  Paricalcitol is more effective than ergocalciferol at decreasing PTH levels in patients with CKD stages 3 or 4 with vitamin D deficiency and SHPT.
authors: Division of Nephrology, Salem Veterans Affairs Medical Center, Salem, VA 24153, USA.
authors: Csaba P
authors: CP
authors: Kovesdy
authors: Jun L
authors: JL
authors: Lu
authors: Sandra M
authors: SM
authors: Malakauskas
authors: Dennis L
authors: DL
authors: Andress
authors: Kamyar
authors: K
authors: Kalantar-Zadeh
authors: Shahram
authors: S
authors: Ahmadzadeh
mesh_terms: D000368:Aged; D004872:Ergocalciferols / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D006962:Hyperparathyroidism, Secondary / Q000188:drug therapy* / Q000209:etiology*; D008297:Male; D051436:Renal Insufficiency, Chronic / Q000150:complications*; D012720:Severity of Illness Index; D014815:Vitamins / Q000627:therapeutic use*
chemical_list: D004872:Ergocalciferols; D014815:Vitamins; C084656:paricalcitol