A randomized trial of cholecalciferol versus doxercalciferol for lowering parathyroid hormone in chronic kidney disease

Sharon Moe, Akber Saifullah, Robert E. LaClair, Sohail A. Usman, Zhangsheng Yu

Research output: Contribution to journalArticle

53 Citations (Scopus)

Abstract

Background and objectives: The optimal treatment of secondary hyperparathyroidism in chronic kidney disease (CKD) is unknown. Design, setting, participants, & measurements: We conducted a randomized, blinded, 3-month trial in vitamin D-deficient CKD stage 3 and 4 patients with parathyroid hormone (PTH) values above the Kidney Disease Outcomes Quality Initiative target, comparing cholecalciferol (4000 IU/d x 1 month, then 2000 IU/d; n = 22) to doxercalciferol (1 μg/d; n = 25). Results: There was no difference in baseline demographics or lab tests, except a slightly higher estimated GFR (eGFR) in the doxercalciferol group. There was a significant increase in vitamin D level in the cholecalciferol group (14 ± 6 to 37 ± 10 ng/ml; P < 0.001) but no change in the doxercalciferol group. The PTH decreased by 27% ± 34% in the doxercalciferol group (P = 0.002) and decreased by 10% ± 31% in the cholecalciferol group (P = 0.16), but the difference between treatments was NS (P = 0.11). Similar results were found when absolute PTH change from baseline to end point was analyzed in a repeated-measures ANOVA model. The serum calcium and urine calcium excretions were not different. Additional non-mineral-related end points, albuminuria, and BP were evaluated, and although trends were present, this did not reach significance. Conclusions: This prospective, randomized trial demonstrated a within-group reduction in PTH in the doxercalciferol-treated patients but no significant difference between the doxercalciferol and cholecalciferol patients. Larger, long-term studies are needed to demonstrate efficacy of mineral-related and non-mineral-related end points and safety.

Original languageEnglish
Pages (from-to)299-306
Number of pages8
JournalClinical Journal of the American Society of Nephrology
Volume5
Issue number2
DOIs
StatePublished - 2010

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Cholecalciferol
Parathyroid Hormone
Chronic Renal Insufficiency
Vitamin D
Calcium
Secondary Hyperparathyroidism
Albuminuria
Kidney Diseases
Minerals
1 alpha-hydroxyergocalciferol
Analysis of Variance
Demography
Urine
Safety
Therapeutics
Serum

ASJC Scopus subject areas

  • Nephrology
  • Transplantation
  • Epidemiology
  • Critical Care and Intensive Care Medicine

Cite this

A randomized trial of cholecalciferol versus doxercalciferol for lowering parathyroid hormone in chronic kidney disease. / Moe, Sharon; Saifullah, Akber; LaClair, Robert E.; Usman, Sohail A.; Yu, Zhangsheng.

In: Clinical Journal of the American Society of Nephrology, Vol. 5, No. 2, 2010, p. 299-306.

Research output: Contribution to journalArticle

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abstract = "Background and objectives: The optimal treatment of secondary hyperparathyroidism in chronic kidney disease (CKD) is unknown. Design, setting, participants, & measurements: We conducted a randomized, blinded, 3-month trial in vitamin D-deficient CKD stage 3 and 4 patients with parathyroid hormone (PTH) values above the Kidney Disease Outcomes Quality Initiative target, comparing cholecalciferol (4000 IU/d x 1 month, then 2000 IU/d; n = 22) to doxercalciferol (1 μg/d; n = 25). Results: There was no difference in baseline demographics or lab tests, except a slightly higher estimated GFR (eGFR) in the doxercalciferol group. There was a significant increase in vitamin D level in the cholecalciferol group (14 ± 6 to 37 ± 10 ng/ml; P < 0.001) but no change in the doxercalciferol group. The PTH decreased by 27{\%} ± 34{\%} in the doxercalciferol group (P = 0.002) and decreased by 10{\%} ± 31{\%} in the cholecalciferol group (P = 0.16), but the difference between treatments was NS (P = 0.11). Similar results were found when absolute PTH change from baseline to end point was analyzed in a repeated-measures ANOVA model. The serum calcium and urine calcium excretions were not different. Additional non-mineral-related end points, albuminuria, and BP were evaluated, and although trends were present, this did not reach significance. Conclusions: This prospective, randomized trial demonstrated a within-group reduction in PTH in the doxercalciferol-treated patients but no significant difference between the doxercalciferol and cholecalciferol patients. Larger, long-term studies are needed to demonstrate efficacy of mineral-related and non-mineral-related end points and safety.",
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AB - Background and objectives: The optimal treatment of secondary hyperparathyroidism in chronic kidney disease (CKD) is unknown. Design, setting, participants, & measurements: We conducted a randomized, blinded, 3-month trial in vitamin D-deficient CKD stage 3 and 4 patients with parathyroid hormone (PTH) values above the Kidney Disease Outcomes Quality Initiative target, comparing cholecalciferol (4000 IU/d x 1 month, then 2000 IU/d; n = 22) to doxercalciferol (1 μg/d; n = 25). Results: There was no difference in baseline demographics or lab tests, except a slightly higher estimated GFR (eGFR) in the doxercalciferol group. There was a significant increase in vitamin D level in the cholecalciferol group (14 ± 6 to 37 ± 10 ng/ml; P < 0.001) but no change in the doxercalciferol group. The PTH decreased by 27% ± 34% in the doxercalciferol group (P = 0.002) and decreased by 10% ± 31% in the cholecalciferol group (P = 0.16), but the difference between treatments was NS (P = 0.11). Similar results were found when absolute PTH change from baseline to end point was analyzed in a repeated-measures ANOVA model. The serum calcium and urine calcium excretions were not different. Additional non-mineral-related end points, albuminuria, and BP were evaluated, and although trends were present, this did not reach significance. Conclusions: This prospective, randomized trial demonstrated a within-group reduction in PTH in the doxercalciferol-treated patients but no significant difference between the doxercalciferol and cholecalciferol patients. Larger, long-term studies are needed to demonstrate efficacy of mineral-related and non-mineral-related end points and safety.

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