title: High-dose cholecalciferol reduces parathyroid hormone in patients with early chronic kidney disease: a pilot, randomized, double-blind, placebo-controlled trial.
abstract: BACKGROUND
  Vitamin D deficiency contributes to secondary hyperparathyroidism, which occurs early in chronic kidney disease (CKD).
  
  
  OBJECTIVE
  We aimed to determine whether high-dose cholecalciferol supplementation for 1 y in early CKD is sufficient to maintain optimal vitamin D status (serum 25-hydroxyvitamin D [25(OH)D] concentration ≥30 ng/mL) and decrease serum parathyroid hormone (PTH). A secondary aim was to determine the effect of cholecalciferol on blood pressure and serum fibroblast growth factor-23 (FGF23).
  
  
  METHODS
  This was a double-blind, randomized, placebo-controlled trial. Forty-six subjects with early CKD (stages 2-3) were supplemented with oral cholecalciferol (vitamin D group; 50,000 IU/wk for 12 wk followed by 50,000 IU every other week for 40 wk) or a matching placebo for 1 y.
  
  
  RESULTS
  By 12 wk, serum 25(OH)D increased in the vitamin D group only [baseline (mean ± SD): 26.7 ± 6.8 to 42.8 ± 16.9 ng/mL; P < 0.05] and remained elevated at 1 y (group-by-time interaction: P < 0.001). PTH decreased from baseline only in the vitamin D group (baseline: 89.1 ± 49.3 to 70.1 ± 24.8 pg/mL; P = 0.01) at 12 wk, but values were not significantly different from baseline at 1 y (75.4 ± 29.5 pg/mL; P = 0.16; group-by-time interaction: P = 0.09). Group differences were more pronounced in participants with secondary hyperparathyroidism (group-by-time interaction: P = 0.004). Blood pressure and FGF23 did not change in either group.
  
  
  CONCLUSIONS
  After 1 y, this oral cholecalciferol regimen was safe and sufficient to maintain serum 25(OH)D concentrations and prevent vitamin D insufficiency in early CKD. Furthermore, serum PTH improved after cholecalciferol treatment, particularly in patients who had secondary hyperparathyroidism.
authors.affiliation: Division of Endocrinology, Metabolism, and Lipids, Emory University School of Medicine, Atlanta, GA, USA.
authors.forename: Jessica A
authors.initials: JA
authors.lastname: Alvarez
authors.forename: Jennie
authors.initials: J
authors.lastname: Law
authors.forename: Kathryn E
authors.initials: KE
authors.lastname: Coakley
authors.forename: Susu M
authors.initials: SM
authors.lastname: Zughaier
authors.forename: Li
authors.initials: L
authors.lastname: Hao
authors.forename: Khadijeh
authors.initials: K
authors.lastname: Shahid Salles
authors.forename: Haimanot
authors.initials: H
authors.lastname: Wasse
authors.forename: Orlando M
authors.initials: OM
authors.lastname: Gutiérrez
authors.forename: Thomas R
authors.initials: TR
authors.lastname: Ziegler
authors.forename: Vin
authors.initials: V
authors.lastname: Tangpricha
mesh_terms: D000368:Aged; D002112:Calcifediol / Q000097:blood; D002762:Cholecalciferol / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004032:Diet / Q000009:adverse effects; D019587:Dietary Supplements / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D000089703:Fibroblast Growth Factor-23; D005845:Georgia / Q000453:epidemiology; D006787:Hospitals, Veterans; D006801:Humans; D006961:Hyperparathyroidism / Q000209:etiology / Q000517:prevention & control*; D006962:Hyperparathyroidism, Secondary / Q000209:etiology / Q000517:prevention & control; D057194:Intention to Treat Analysis; D008297:Male; D008875:Middle Aged; D010281:Parathyroid Hormone / Q000097:blood*; D010865:Pilot Projects; D015995:Prevalence; D051436:Renal Insufficiency, Chronic / Q000097:blood* / Q000209:etiology / Q000503:physiopathology*; D012720:Severity of Illness Index; D014808:Vitamin D Deficiency / Q000097:blood / Q000178:diet therapy* / Q000209:etiology / Q000503:physiopathology
chemical_list: C000717427:FGF23 protein, human; C470125:PTH protein, human; D010281:Parathyroid Hormone; D002762:Cholecalciferol; D000089703:Fibroblast Growth Factor-23; D002112:Calcifediol