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High doses of cholecalciferol alleviate the progression of hyperparathyroidism in patients with CKD Stages 3-4 : Results of a 12-week double-blind, randomized, controlled study

Westerberg, Per-Anton ; Sterner, Gunnar LU ; Ljunggren, Östen ; Isaksson, Elin LU ; Elvarson, Fjölnir ; Dezfoolian, Hamid and Linde, Torbjörn (2018) In Nephrology Dialysis Transplantation 33(3). p.466-471
Abstract

Background 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). Methods 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. Results Baseline calcidiol was 57.5 ± 22 and 56.8 ± 22... (More)

Background 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). Methods 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. Results 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. Conclusion 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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author
; ; ; ; ; and
publishing date
type
Contribution to journal
publication status
published
subject
keywords
cholecalciferol, chronic renal failure, FGF23, secondary hyperparathyroidism, Vitamin D
in
Nephrology Dialysis Transplantation
volume
33
issue
3
pages
466 - 471
publisher
Oxford University Press
external identifiers
  • pmid:29156056
  • scopus:85043369390
ISSN
0931-0509
DOI
10.1093/ndt/gfx059
language
English
LU publication?
no
id
b2deeeb2-e32d-4e63-ad7a-2f604fa38948
date added to LUP
2018-04-09 15:00:37
date last changed
2024-05-13 08:03:49
@article{b2deeeb2-e32d-4e63-ad7a-2f604fa38948,
  abstract     = {{<p>Background 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). Methods 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. Results 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 &lt; 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. Conclusion 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.</p>}},
  author       = {{Westerberg, Per-Anton and Sterner, Gunnar and Ljunggren, Östen and Isaksson, Elin and Elvarson, Fjölnir and Dezfoolian, Hamid and Linde, Torbjörn}},
  issn         = {{0931-0509}},
  keywords     = {{cholecalciferol; chronic renal failure; FGF23; secondary hyperparathyroidism; Vitamin D}},
  language     = {{eng}},
  month        = {{03}},
  number       = {{3}},
  pages        = {{466--471}},
  publisher    = {{Oxford University Press}},
  series       = {{Nephrology Dialysis Transplantation}},
  title        = {{High doses of cholecalciferol alleviate the progression of hyperparathyroidism in patients with CKD Stages 3-4 : Results of a 12-week double-blind, randomized, controlled study}},
  url          = {{http://dx.doi.org/10.1093/ndt/gfx059}},
  doi          = {{10.1093/ndt/gfx059}},
  volume       = {{33}},
  year         = {{2018}},
}