The impact of cholecalciferol on markers of vascular calcification in hemodialysis patients: A randomized placebo controlled study
El Borolossy, Radwa;
Abstract
Background and aim: Vascular calcification is an independent risk factor for cardiovascular
diseases and all-cause mortality in end stage renal disease, and particularly in hemodialysis
patients. Vitamin D deficiency has been shown to be associated with vascular calcification among
this category of patients. Cholecalciferol or vitamin D3; the native inactivated 25-hydroxy
vitamin D [25(OH)D], has been proposed to have a good impact on vascular calcification and
vitamin D deficiency. However, clinical data is still limited.
Methods and results: A prospective, randomized, placebo-controlled study was carried out to
evaluate the effect of oral cholecalciferol on vascular calcification and 25(OH)D levels in hemodialysis
patients. A total of sixty eligible hemodialysis patients were randomly assigned to either
a treatment group (Oral 200.000IU Cholecalciferol per month) or a placebo group, for 3 months.
Serum 25-hydroxy vitamin D (25(OH)D), fetuin-A, fibroblast growth factor (FGF-23), osteoprotegerin
(OPG), calcium, phosphorus, their product (CaXP) and intact parathyroid hormone (iPTH)
levels, were all assessed at baseline and at the end of the study. ClinicalTrials.gov registration
number: NCT03602430. Cholecalciferol significantly increased serum levels of 25(OH)D and
fetuin-A in the treatment group (p-value < 0.001), while no significant difference was observed
in the placebo group. Cholecalciferol administration showed no effect on either FGF-23 or OPG.
None of the treatment group patients experienced any adverse effects.
Conclusion: Cholecalciferol was shown to be an effective, tolerable, inexpensive pharmacotherapeutic
option to overcome vitamin D deficiency, with a possible modulating effect on fetuin-A,
among hemodialysis patients.
diseases and all-cause mortality in end stage renal disease, and particularly in hemodialysis
patients. Vitamin D deficiency has been shown to be associated with vascular calcification among
this category of patients. Cholecalciferol or vitamin D3; the native inactivated 25-hydroxy
vitamin D [25(OH)D], has been proposed to have a good impact on vascular calcification and
vitamin D deficiency. However, clinical data is still limited.
Methods and results: A prospective, randomized, placebo-controlled study was carried out to
evaluate the effect of oral cholecalciferol on vascular calcification and 25(OH)D levels in hemodialysis
patients. A total of sixty eligible hemodialysis patients were randomly assigned to either
a treatment group (Oral 200.000IU Cholecalciferol per month) or a placebo group, for 3 months.
Serum 25-hydroxy vitamin D (25(OH)D), fetuin-A, fibroblast growth factor (FGF-23), osteoprotegerin
(OPG), calcium, phosphorus, their product (CaXP) and intact parathyroid hormone (iPTH)
levels, were all assessed at baseline and at the end of the study. ClinicalTrials.gov registration
number: NCT03602430. Cholecalciferol significantly increased serum levels of 25(OH)D and
fetuin-A in the treatment group (p-value < 0.001), while no significant difference was observed
in the placebo group. Cholecalciferol administration showed no effect on either FGF-23 or OPG.
None of the treatment group patients experienced any adverse effects.
Conclusion: Cholecalciferol was shown to be an effective, tolerable, inexpensive pharmacotherapeutic
option to overcome vitamin D deficiency, with a possible modulating effect on fetuin-A,
among hemodialysis patients.
Other data
Title | The impact of cholecalciferol on markers of vascular calcification in hemodialysis patients: A randomized placebo controlled study | Authors | El Borolossy, Radwa | Issue Date | 21-Sep-2020 | Publisher | Elsevier | Journal | Nutrition , Metabolism and cardiovascular disease | Volume | 31 | Start page | 626 | End page | 636 |
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