title: Randomized controlled trial of cholecalciferol supplementation in chronic kidney disease patients with hypovitaminosis D.
abstract: BACKGROUND
  Hypovitaminosis D is common in chronic kidney disease (CKD). Effects of 25-hydroxyvitamin D replenishment in CKD are not well described.
  
  
  METHODS
  An 8-week randomized, placebo-controlled, double-blind parallel intervention study was conducted in haemodialysis (HD) and non-HD CKD patients. Treatment consisted of 40,000 IU of cholecalciferol orally per week. Plasma 25-hydroxyvitamin D (25-OHD), plasma 1,25-dihydroxyvitamin D (1,25-diOHD), plasma parathyroid hormone (PTH), serum phosphate, ionized serum calcium and serum fibroblast growth factor 23 (FGF-23) were analysed. We also investigated biomarkers related to cardiovascular disease (plasma D-dimer, plasma fibrinogen, plasma von Willebrand factor antigen and activity, plasma interleukin 6, plasma C-reactive protein, blood pressure, aortic augmentation index, aortic pulse wave velocity and 24-h urinary protein loss). Objective and subjective health variables were assessed (muscle function tests, visual analogue scores and Health Assessment Questionnaire).
  
  
  RESULTS
  Fifty-two CKD patients with 25-OHD <50 nmol/L at screening were included. Cholecalciferol supplementation led to a significant increase to a median of 155 nmol/L 25-OHD (interquartile range 137-173 nmol/L) in treated patients (n = 25, P < 0.001). In non-HD patients, we saw a significant increase in 1,25-diOHD (n = 13, P < 0.01) and a lowering of PTH (n = 13, P < 0.001). This was not observed in HD patients. Cholecalciferol supplementation caused a significant increase in serum calcium and FGF-23.
  
  
  CONCLUSIONS
  25-OHD replenishment was effectively obtained with the employed cholecalciferol dosing. In non-HD patients, it had favourable effects on 1,25-diOHD and PTH. Vitamin D-supplemented patients must be monitored for hypercalcaemia. The present study could not identify significant pleiotropic effects of 25-OHD replenishment.
authors: Clinical Research Unit, Department of Nephrology, Odense University Hospital, Odense, Denmark. peter.marckmann@dadlnet.dk
authors: Peter
authors: P
authors: Marckmann
authors: Hanne
authors: H
authors: Agerskov
authors: Sasikala
authors: S
authors: Thineshkumar
authors: Else-Marie
authors: EM
authors: Bladbjerg
authors: Johannes J
authors: JJ
authors: Sidelmann
authors: Jørgen
authors: J
authors: Jespersen
authors: Mads
authors: M
authors: Nybo
authors: Lars M
authors: LM
authors: Rasmussen
authors: Ditte
authors: D
authors: Hansen
authors: Alexandra
authors: A
authors: Scholze
mesh_terms: D000368:Aged; D015415:Biomarkers / Q000032:analysis; D002113:Calcification, Physiologic; D002762:Cholecalciferol / Q000008:administration & dosage*; D019587:Dietary Supplements; D004311:Double-Blind Method; D005260:Female; D000089703:Fibroblast Growth Factor-23; D005919:Glomerular Filtration Rate; D006801:Humans; D008297:Male; D008875:Middle Aged; D009132:Muscles / Q000502:physiology; D011379:Prognosis; D051436:Renal Insufficiency, Chronic / Q000150:complications*; D014808:Vitamin D Deficiency / Q000209:etiology / Q000378:metabolism / Q000517:prevention & control*; D014815:Vitamins / Q000008:administration & dosage*
chemical_list: D015415:Biomarkers; C000717427:FGF23 protein, human; D014815:Vitamins; D002762:Cholecalciferol; D000089703:Fibroblast Growth Factor-23