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
(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
- Westerberg, Per-Anton ; Sterner, Gunnar LU ; Ljunggren, Östen ; Isaksson, Elin LU ; Elvarson, Fjölnir ; Dezfoolian, Hamid and Linde, Torbjörn
- publishing date
- 2018-03-01
- 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
-
- scopus:85043369390
- pmid:29156056
- 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
- 2024-07-08 12:13:03
@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 < 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}}, }