The Efficacy and Safety of High-Dose Cholecalciferol Therapy in Hemodialysis Patients

Abstract

Vitamin D deficiency and insufficiency are highly prevalent in CKD, affecting over 80% of hemodialysis (HD) patients and requiring therapeutic intervention. Nephrological societies suggest the administration of cholecalciferol according to the guidelines for the general population. The aim of the observational study was to evaluate the efficacy and safety of the therapy with a high dose of cholecalciferol in HD patients with 25(OH)D deficiency and insufficiency to reach the target serum 25(OH)D level > 30 ng/mL. A total of 22 patients (16 M), with an average age of 72.5 ± 13.03 years and 25(OH)D concentration of 13.05 (9.00-17.90) ng/mL, were administered cholecalciferol at a therapeutic dose of 70,000 IU/week (20,000 IU + 20,000 IU + 30,000 IU, immediately after each dialysis session). All patients achieved the target value > 30 ng/mL, with a mean time of 2.86 ± 1.87 weeks. In the first week, the target level of 25(OH)D (100%) was reached by 2 patients (9.09%), in the second week by 15 patients (68.18%), in the fourth week by 18 patients (81.18%), and in the ninth week by all 22 patients (100%). A significant increase in 1,25(OH)₂D levels was observed during the study. However, only 2 patients (9.09%) achieved a concentration of 1,25(OH)₂D above 25 ng/mL-the lower limit of the reference range. The intact PTH concentrations remained unchanged during the observation period. No episodes of hypercalcemia were detected, and one new episode of hyperphosphatemia was observed. In conclusion, our study showed that the administration of a high-therapeutic dose of cholecalciferol allowed for a quick, effective, and safe leveling of 25(OH)D concentration in HD patients.

Keywords: 25-hydroxycholecalciferol; calcidiol; calcitriol; cholecalciferol; chronic kidney disease; chronic kidney disease–mineral and bone disorder; hemodialysis; parathyroid hormone; vitamin D.

Figure 1

The flow diagram of patient selection. * = vitamin D deficiency 25(OH)D < 20 ng/mL; vitamin D insufficiency 25(OH)D 20–29 ng/mL).

Figure 2

Number of patients who reached the target 25(OH)D concentration (bars) and the cumulative dose of cholecalciferol (line).

Figure 3

Serum concentrations of intact parathormone (iPTH, part (A)), calcidiol (25(OH)D, part (B)), and calcitriol (1,25(OH)₂D, part (C)) before supplementation (T0) and after reaching the target serum 25(OH)D concentration (Tmax).

Figure 4

Correlation between serum concentrations of calcidiol (25(OH)D), and calcitriol (1,25(OH)₂D) during the therapy with cholecalciferol. Each white circle represents each data point, both types of lines represent the 0.95 confidence interval value as described above.

Figure 5

Serum concentrations of calcium (Ca, part (A)), and phosphorus (Pi, part (B)) before supplementation (T0) and after reaching the target serum calcidiol concentration (Tmax).