Cholecalciferol supplementation increases FGF23 in peritoneal dialysis patients with hypovitaminosis D: a randomized clinical trial
Ramirez-Sandoval JC, Arvizu-Hernandez M, Cruz C, Vazquez-Cantu B, Rojas-Concha LJ, Tamez L, Reynerio F, Gomez FE, Correa-Rotter R
Journal of nephrology · 5 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
- Funding not disclosed
Publication
- Published
- 2019-03-19 · J Nephrol · vol. 32 · issue 4 · pp. 645–659
- Publisher
- Springer Science+Business Media
- Cited
- 11 citations · more than 69% of similar papers · 0.9× the field average
- References
- 70 works
- Access
- Paywalled
- Research areas
- Parathyroid Disorders and Treatments · Vitamin D Research Studies · Dialysis and Renal Disease Management
- Keywords
- Medicine, Cholecalciferol, Vitamin D and neurology, Placebo, Internal medicine, Peritoneal dialysis, Endocrinology, Parathyroid hormone, Randomized controlled trial, Osteoprotegerin, Secondary hyperparathyroidism, vitamin D deficiency, Gastroenterology, Calcium, Pathology
- MeSH
- humans, vitamin d deficiency, cholecalciferol, parathyroid hormone, fibroblast growth factors, vitamins, vitamin d, osteocalcin, interleukin-6, peritoneal dialysis, prospective studies, double-blind method, dietary supplements, adult, aged, middle aged, female, male, renal insufficiency, chronic, osteopontin, osteoprotegerin, carotid intima-media thickness, biomarkers, fibroblast growth factor-23
9 authors
From MX
- Juan Carlos Ramirez-SandovalInstituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
- Mauricio Arvizu-HernándezInstituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
- Cristino CruzInstituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
- Barbara Vazquez-CantuInstituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
- Luis J. Rojas‐ConchaInstituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
- Luis Tamez‐PedrozaInstituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Abstract
Background
Vitamin D deficiency is common in peritoneal dialysis (PD) patients, so its supplementation has been advocated as potentially beneficial.
Methods
Double-blind, placebo-controlled, randomized clinical trial. Subjects on PD treated with high calcium peritoneal dialysate (Ca 3.5 mEq/l) and serum levels of 25-hydroxi vitamin D (25D) < 20 ng/ml were randomized to receive cholecalciferol (4800 IU/daily) or placebo for 16 weeks. The outcome measures were the effects on the osteogenic biomarkers osteoprotegerin (primary endpoint), intact fibroblast growth factor-23 (iFGF23), osteocalcin, osteopontin, iPTH, 1,25-dyhydroxivitamin D (1,25D), and interleukin-6.
Results
Fifty-eight subjects were randomly assigned. Baseline characteristics were similar in both groups. Cholecalciferol supplemented subjects had a significant increase in serum 25D (from 11.4 ± 5.0 to 28.3 ± 10.3 ng/ml), 1,25D and iFGF23 compared with placebo group. iFGF23 levels increased an average of 10,875 pg/ml per month (95% CI 11,778-88,414) in the cholecalciferol group and was unchanged in the placebo group (2829 pg/ml, 95% CI - 2181 to 14,972). Extremely high iFGF23 levels (> 30,000 pg/ml) were observed in 74% of subjects receiving cholecalciferol although iFGF23 returned to baseline values after 32 weeks of withdrawal. The observed changes in iFGF23 correlated with 1,25D levels and were not modified by other variables. No difference was observed between groups in osteoprotegerin or other osteogenic biomarkers levels.
Conclusions
Cholecalciferol supplementation increases serum 25D levels in subjects on PD exposed to high calcium dialysate, yet it induces an exponential increase of iFGF23 in most patients, which disappear after withdrawal of supplementation and may be a major concern for this maneuver.
Abstract via Europe PMC. Copyright remains with the authors or publisher.
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