A randomized trial of cholecalciferol versus doxercalciferol for lowering parathyroid hormone in chronic kidney disease.
OBJECTIVE
The optimal treatment of secondary hyperparathyroidism in chronic kidney disease (CKD) is unknown.


METHODS
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 microg/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.
Moe
Sharon M
SM
Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana 46202, USA. smoe@iupui.edu
Saifullah
Akber
A
LaClair
Robert E
RE
Usman
Sohail A
SA
Yu
Zhangsheng
Z
D000368:Aged; D015415:Biomarkers / Q000097:blood / Q000652:urine; D002118:Calcium / Q000097:blood / Q000652:urine; D002762:Cholecalciferol / Q000009:adverse effects / Q000627:therapeutic use*; D002908:Chronic Disease; D004872:Ergocalciferols / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D006962:Hyperparathyroidism, Secondary / Q000097:blood / Q000188:drug therapy* / Q000209:etiology; D007674:Kidney Diseases / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010281:Parathyroid Hormone / Q000097:blood*; D011446:Prospective Studies; D016037:Single-Blind Method; D013997:Time Factors; D016896:Treatment Outcome; D014807:Vitamin D / Q000097:blood; D014808:Vitamin D Deficiency / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D014815:Vitamins / Q000009:adverse effects / Q000627:therapeutic use*
D015415:Biomarkers; D004872:Ergocalciferols; C470125:PTH protein, human; D010281:Parathyroid Hormone; D014815:Vitamins; D014807:Vitamin D; D002762:Cholecalciferol; C042533:1 alpha-hydroxyergocalciferol; D002118:Calcium