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Cholecalciferol supplementation increases FGF23 in peritoneal dialysis patients with hypovitaminosis D: a randomized clinical trial.
J Nephrol. 2019 Aug; 32(4):645-659.JN

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.

Authors+Show Affiliations

Department of Nephrology and Mineral Metabolism, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Vasco de Quiroga 15, Belisario Dominguez Sección XVI, 14080, Mexico City, Mexico.Department of Nephrology and Mineral Metabolism, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Vasco de Quiroga 15, Belisario Dominguez Sección XVI, 14080, Mexico City, Mexico.Department of Nephrology and Mineral Metabolism, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Vasco de Quiroga 15, Belisario Dominguez Sección XVI, 14080, Mexico City, Mexico.Department of Nephrology and Mineral Metabolism, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Vasco de Quiroga 15, Belisario Dominguez Sección XVI, 14080, Mexico City, Mexico.Department of Nephrology and Mineral Metabolism, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Vasco de Quiroga 15, Belisario Dominguez Sección XVI, 14080, Mexico City, Mexico.Department of Nephrology and Mineral Metabolism, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Vasco de Quiroga 15, Belisario Dominguez Sección XVI, 14080, Mexico City, Mexico.Nutritional Physiology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.Central Laboratory, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.Department of Nephrology and Mineral Metabolism, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Vasco de Quiroga 15, Belisario Dominguez Sección XVI, 14080, Mexico City, Mexico. correarotter@gmail.com.

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

30888584

Citation

Ramirez-Sandoval, Juan C., et al. "Cholecalciferol Supplementation Increases FGF23 in Peritoneal Dialysis Patients With Hypovitaminosis D: a Randomized Clinical Trial." Journal of Nephrology, vol. 32, no. 4, 2019, pp. 645-659.
Ramirez-Sandoval JC, Arvizu-Hernandez M, Cruz C, et al. Cholecalciferol supplementation increases FGF23 in peritoneal dialysis patients with hypovitaminosis D: a randomized clinical trial. J Nephrol. 2019;32(4):645-659.
Ramirez-Sandoval, J. C., Arvizu-Hernandez, M., Cruz, C., Vazquez-Cantu, B., Rojas-Concha, L. J., Tamez, L., Reynerio, F., Gomez, F. E., & Correa-Rotter, R. (2019). Cholecalciferol supplementation increases FGF23 in peritoneal dialysis patients with hypovitaminosis D: a randomized clinical trial. Journal of Nephrology, 32(4), 645-659. https://doi.org/10.1007/s40620-019-00599-x
Ramirez-Sandoval JC, et al. Cholecalciferol Supplementation Increases FGF23 in Peritoneal Dialysis Patients With Hypovitaminosis D: a Randomized Clinical Trial. J Nephrol. 2019;32(4):645-659. PubMed PMID: 30888584.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Cholecalciferol supplementation increases FGF23 in peritoneal dialysis patients with hypovitaminosis D: a randomized clinical trial. AU - Ramirez-Sandoval,Juan C, AU - Arvizu-Hernandez,Mauricio, AU - Cruz,Cristino, AU - Vazquez-Cantu,Barbara, AU - Rojas-Concha,Luis J, AU - Tamez,Luis, AU - Reynerio,Fagundo, AU - Gomez,F Enrique, AU - Correa-Rotter,Ricardo, Y1 - 2019/03/19/ PY - 2018/11/22/received PY - 2019/03/07/accepted PY - 2019/3/20/pubmed PY - 2020/8/19/medline PY - 2019/3/20/entrez KW - 25-hydroxi vitamin D KW - Dialysis KW - End stage renal disease KW - Osteoprotegerin KW - Vitamin D SP - 645 EP - 659 JF - Journal of nephrology JO - J Nephrol VL - 32 IS - 4 N2 - 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. SN - 1724-6059 UR - https://www.unboundmedicine.com/medline/citation/30888584/Cholecalciferol_supplementation_increases_FGF23_in_peritoneal_dialysis_patients_with_hypovitaminosis_D:_a_randomized_clinical_trial_ L2 - https://dx.doi.org/10.1007/s40620-019-00599-x DB - PRIME DP - Unbound Medicine ER -