Journal
NEPHROLOGY DIALYSIS TRANSPLANTATION
Volume 33, Issue 3, Pages 466-471Publisher
OXFORD UNIV PRESS
DOI: 10.1093/ndt/gfx059
Keywords
cholecalciferol; chronic renal failure; FGF23; secondary hyperparathyroidism; vitamin D
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Funding
- Uppsala University Hospital
- Renapharma AB
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Calcidiol insufficiency may accelerate the development of secondary hyperparathyroidism (SHPT). We tested the effect of a substantial increase in calcidiol on mineral metabolism in patients with chronic kidney disease (CKD). Ninety-five patients with CKD Stages 3-4, parathyroid hormone (PTH) above 6.8 pmol/L and calcidiol below 75 nmol/L were randomized to receive either cholecalciferol 8000 IU/day or placebo for 12 weeks. The primary endpoint was difference in the mean change in iPTH after 12 weeks. The proportion of participants having a 30% reduction in PTH and the effect on hand grip strength, fatigue and different biochemical variables were also investigated. Baseline calcidiol was 57.5 +/- 22 and 56.8 +/- 22 nmol/L in the cholecalciferol and placebo groups, respectively. The corresponding concentrations of PTH were 10.9 +/- 5 and 13.1 +/- 9 pmol/L. Calcidiol increased to 162 +/- 49 nmol/L in patients receiving cholecalciferol, and PTH levels remained constant at 10.5 +/- 5 pmol/L. In the placebo group, calcidiol remained stable and PTH increased to 15.2 +/- 11 pmol/L. The mean change in PTH differed significantly between the two groups (P < 0.01). The proportion of subjects reaching a 30% decrease in PTH did not differ. No effect on grip strength, fatigue, phosphate or fibroblast growth factor 23 was observed. Cholecalciferol treatment resulted in stable calcium concentrations and a substantial increase in calcitriol. Treatment with high daily doses of cholecalciferol in patients with CKD Stages 3-4 halts the progression of SHPT and does not cause hypercalcaemia or other side effects.
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