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 PA, Sterner G, Ljunggren Ö, Isaksson E, Elvarson F, Dezfoolian H, Linde T
Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 37 citations
Review labels
Neutral facts our review recorded about how this study was done. They describe method, never whether we like the result.
How it was studied
- Design
- Randomized controlled trial (indexed by PubMed)
- Studied in
- People
- Main outcome
- Health markers and function
Who paid for it
- Funding
- Industry funded
Based on full-text disclosure statement.
Publication
- Published
- 2017-03-12 · Nephrol Dial Transplant · vol. 33 · issue 3 · pp. 466–471
- Publisher
- Oxford University Press
- Cited
- 55 citations · more than 90% of similar papers · 2.5× the field average
- References
- 18 works
- Access
- Open access (hybrid journal) · CC-BY-NC
- Research areas
- Parathyroid Disorders and Treatments · Bone health and treatments · Vitamin D Research Studies
- Keywords
- Cholecalciferol, Secondary hyperparathyroidism, Internal medicine, Medicine, Endocrinology, Calcitriol, Parathyroid hormone, Hyperparathyroidism, Vitamin D and neurology, Placebo, Hypercalcaemia, Kidney disease, Fibroblast growth factor 23, Calcium
- MeSH
- humans, hyperparathyroidism, secondary, disease progression, calcium, cholecalciferol, fibroblast growth factors, prognosis, double-blind method, aged, middle aged, female, male, renal insufficiency, chronic, calcium-regulating hormones and agents, fibroblast growth factor-23
7 authors
From SE
- Per-Anton WesterbergUppsala University
- Gunnar SternerSkåne University Hospital
- Östen LjunggrenUppsala University
- Elin IsakssonSkåne University Hospital
- Fjölnir ElvarsonUppsala University
- Hamid DezfoolianSahlgrenska University Hospital
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 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.
Abstract via Europe PMC. Copyright remains with the authors or publisher (CC BY-NC).
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