Randomized controlled trial of cholecalciferol supplementation in chronic kidney disease patients with hypovitaminosis D
Marckmann P, Agerskov H, Thineshkumar S, Bladbjerg EM, Sidelmann JJ, Jespersen J, Nybo M, Rasmussen LM, Hansen D, Scholze A
Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 112 citas
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación independiente
- Organización sin fines de lucro
- Lægeforeningen
Según 1 financiador declarado.
Publicación
- Publicado
- 2012-07-20 · Nephrol Dial Transplant · vol. 27 · número 9 · págs. 3523–3531
- Editorial
- Oxford University Press
- Citado
- 146 citas · más que el 98% de estudios similares · 9.5× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 47 trabajos
- Acceso
- De pago
- Áreas de investigación
- Parathyroid Disorders and Treatments · Vitamin D Research Studies · Dialysis and Renal Disease Management
- Palabras clave
- vitamin D3 supplementation, vitamin D deficiency, chronic kidney disease, 25-hydroxyvitamin D, 1,25-dihydroxyvitamin D, parathyroid hormone, hemodialysis, fibroblast growth factor 23, hypercalcemia, cardiovascular biomarkers, muscle function
- MeSH
- muscles, humans, vitamin d deficiency, cholecalciferol, vitamins, glomerular filtration rate, prognosis, double-blind method, calcification, physiologic, dietary supplements, aged, middle aged, female, male, renal insufficiency, chronic, biomarkers, fibroblast growth factor-23
10 autores
- Peter Marckmann🇩🇰 · autor de correspondenciaUniversity of Southern Denmark; Odense University Hospital
- Hanne Agerskov🇩🇰Odense University Hospital
- Sasikala Thineshkumar🇩🇰University of Southern Denmark; Odense University Hospital
- Else‐Marie Bladbjerg🇩🇰University of Southern Denmark; Hospital South West Jutland
- Johannes Jakobsen Sidelmann🇩🇰University of Southern Denmark; Hospital South West Jutland
- Jørgen Jespersen🇩🇰University of Southern Denmark; Hospital South West Jutland
- Mads Nybo🇩🇰Odense University Hospital
- Lars Melholt Rasmussen🇩🇰Odense University Hospital
- Ditte Hansen🇩🇰Roskilde Sygehus
- Alexandra Scholze🇩🇰University of Southern Denmark; Odense University Hospital
Resumen
El texto original del estudio, en el idioma en que se publicó.
Background
Hypovitaminosis D is common in chronic kidney disease (CKD). Effects of 25-hydroxyvitamin D replenishment in CKD are not well described.
Methods
An 8-week randomized, placebo-controlled, double-blind parallel intervention study was conducted in haemodialysis (HD) and non-HD CKD patients. Treatment consisted of 40,000 IU of cholecalciferol orally per week. Plasma 25-hydroxyvitamin D (25-OHD), plasma 1,25-dihydroxyvitamin D (1,25-diOHD), plasma parathyroid hormone (PTH), serum phosphate, ionized serum calcium and serum fibroblast growth factor 23 (FGF-23) were analysed. We also investigated biomarkers related to cardiovascular disease (plasma D-dimer, plasma fibrinogen, plasma von Willebrand factor antigen and activity, plasma interleukin 6, plasma C-reactive protein, blood pressure, aortic augmentation index, aortic pulse wave velocity and 24-h urinary protein loss). Objective and subjective health variables were assessed (muscle function tests, visual analogue scores and Health Assessment Questionnaire).
Results
Fifty-two CKD patients with 25-OHD <50 nmol/L at screening were included. Cholecalciferol supplementation led to a significant increase to a median of 155 nmol/L 25-OHD (interquartile range 137-173 nmol/L) in treated patients (n = 25, P < 0.001). In non-HD patients, we saw a significant increase in 1,25-diOHD (n = 13, P < 0.01) and a lowering of PTH (n = 13, P < 0.001). This was not observed in HD patients. Cholecalciferol supplementation caused a significant increase in serum calcium and FGF-23.
Conclusions
25-OHD replenishment was effectively obtained with the employed cholecalciferol dosing. In non-HD patients, it had favourable effects on 1,25-diOHD and PTH. Vitamin D-supplemented patients must be monitored for hypercalcaemia. The present study could not identify significant pleiotropic effects of 25-OHD replenishment.
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