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Background: Secondary hyperparathyroidism is prevalent among hemodialysis patients associated with vascular and skeletal complications. Thus, treatment is required, specially before kidney transplantation. Objectives: This study aimed to compare the efficacy of calcitriol and cinacalcet versus standard-dose calcitriol in treating severe secondary hyperparathyroidism in hemodialysis patients. Methods: This randomized clinical trial was conducted on 70 hemodialysis patients with severe secondary hyperparathyroidism who were randomly allocated to two intervention groups. Group A received calcitriol 1mg PO every other night, and group B took calcitriol 1mg PO every other night and cinacalcet 30mg PO daily. The improvement of laboratory parameters was investigated 3 and 6 months after the intervention. Results: There was no significant difference between the two groups regarding age, sex, body mass index, and duration of dialysis (P > 0.05). In group A, serum levels of calcium (P < 0.001) and parathyroid hormone (PTH) (P < 0.001) were significantly reduced compared to baseline. However, phosphorus (P = 0.175) and albumin (P = 0.143) serum levels showed no significant changes. In group B, calcium (P = 0.001), PTH (P < 0.001), and serum phosphorus (P < 0.001) levels were significantly decreased after the intervention. Nevertheless, serum albumin levels showed no significant changes from baseline (P = 0.061). Changes in serum phosphorus (P < 0.001) and PTH levels (P < 0.001) were significantly different between the groups. However, changes in serum calcium (P = 0.062) and albumin levels (P = 0.773) were not significantly different (Wilcoxon signed-rank test). Conclusions: The results of this study showed that treatment with cinacalcet and calcitriol was more effective than calcitriol alone without any side effects.

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