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Objective: To evaluate the parathyroid hormone (PTH)-lowering effect, safety, and tolerability of high-dose ergocalciferol compared with conventional-dose ergocalciferol in CKD subjects.
Material and Method: We enrolled CKD stage III-IV patients who had 25-hydroxyvitamin D (25-OH-D) level <30 ng/mL. The patients were randomized into two groups, control group treated with ergocalciferol as recommended by K/DOQI guidelines, and treatment group treated with double dosage of ergocalciferol from the recommendation. We compared serum 25-OH-D, intact-PTH, phosphate, calcium, and bone biomarker levels, during the 8-week intervention.
Results: Sixty-eight patients were included (34 controls and 34 treatments). Baseline characteristics of both groups were similar except calcium level 9.12±0.56 mg/dL in control group and 9.44±0.38 mg/dL in treatment group (p = 0.009), but not clinically significant. At the end of the 8-week, the mean 25-OH-D level significantly increased from 20.99±6.68 to 33.41±8.92 ng/mL in the treatment group (p = 0.001) and increased from 20.84±7.21 to 23.42±7.89 ng/mL in the control group (p = 0.026). There was also a significantly greater increase of 25-OH-D levels in the treatment group. Additionally, PTH levels significantly decreased from 90.75±67.12 to 76.40±45.97 at 8 weeks (p = 0.024) in the treatment group, and there was no change in the control group (97.14±83.52 vs. 101.13±95.03 pg/mL, p = 0.546). Serum calcium, phosphate, and adverse effects did not significantly change in either group throughout the study.
Conclusion: In addition to improving vitamin D levels, oral high-dose ergocalciferol was safe and had a beneficial effect in decreasing PTH in patients with stage III-IV of CKD.
Keywords: Hyperparathyroidism, Chronic kidney disease, Ergocalciferol