Randomized controlled trial of cholecalciferol supplementation in chronic kidney disease patients with hypovitaminosis D

Nephrol Dial Transplant. 2012 Sep;27(9):3523-31. doi: 10.1093/ndt/gfs138. Epub 2012 Jul 20.

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.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Biomarkers / analysis
  • Calcification, Physiologic
  • Cholecalciferol / administration & dosage*
  • Dietary Supplements*
  • Double-Blind Method
  • Female
  • Fibroblast Growth Factor-23
  • Glomerular Filtration Rate
  • Humans
  • Male
  • Middle Aged
  • Muscles / physiology
  • Prognosis
  • Renal Insufficiency, Chronic / complications*
  • Vitamin D Deficiency / etiology
  • Vitamin D Deficiency / metabolism
  • Vitamin D Deficiency / prevention & control*
  • Vitamins / administration & dosage*

Substances

  • Biomarkers
  • FGF23 protein, human
  • Vitamins
  • Cholecalciferol
  • Fibroblast Growth Factor-23