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 · 38 citas
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Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiado por la industria
Según la declaración de financiación del texto completo.
Publicación
- Publicado
- 2017-03-12 · Nephrol Dial Transplant · vol. 33 · número 3 · págs. 466–471
- Editorial
- Oxford University Press
- Citado
- 55 citas · más que el 90% de estudios similares · 2.5× el promedio de su campo
- Referencias
- 18 trabajos
- Acceso
- Acceso abierto (revista híbrida) · CC-BY-NC
- Áreas de investigación
- Parathyroid Disorders and Treatments · Bone health and treatments · Vitamin D Research Studies
- Palabras clave
- 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 autores
- Per-Anton Westerberg🇸🇪Uppsala University
- Gunnar Sterner🇸🇪Skåne University Hospital
- Östen Ljunggren🇸🇪Uppsala University
- Elin Isaksson🇸🇪Skåne University Hospital
- Fjölnir Elvarson🇸🇪Uppsala University
- Hamid Dezfoolian🇸🇪Sahlgrenska University Hospital
- Torbjörn Linde🇸🇪 · autor de correspondenciaUppsala University
Resumen
El texto original del estudio, en el idioma en que se publicó.
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.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial (CC BY-NC).
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