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Abstract: TH-OR028

Cholecalciferol vs Small Doses of Alfacalcidol in Hemodialysis Patients: A Randomized Placebo-Controlled Study

Session Information

Category: Bone and Mineral Metabolism

  • 402 Bone and Mineral Metabolism: Clinical

Authors

  • Kulicki, Pawel, Medical University of Warsaw, Warsaw, Poland
  • Niemczyk, Stanislaw, Military Medical Institute of Warsaw, Warsaw, Poland
  • Zebrowski, Pawel, Medical University of Warsaw, Warsaw, Poland
  • Malyszko, Jolanta, Warsaw Medical University, Warsaw, Poland
  • Matuszkiewicz-Rowinska, Joanna, Medical University of Warsaw, Warsaw, Poland
Background

The ability of extrarenal tissues to convert 25OHD into 1,25(OH)2D and its dependence on substrate levels provide the rationale for supplementing vitamin D in dialysis patients who usually have severe depletion of both: calctriol and vitamin D. The primary aim of the study was to compare effects of cholecalciferol (CHOL, 4000 IU) with frequently used in Europe, small doses of alfacalcidol (ALFA, 0.5 microg) or placebo (PLC), given thrice weekly for 12 weeks, on serum 1,25(OH)2D in hemodialysis (HD) patients with vitamin D deficiency. Secondary outcomes were changes in serum calcium, phosphate, 25(OH)D, parathyroid hormone (PTH), fibroblast growth factor 23 (FGF23) and sclerostin during the treatment.

Methods

This was a prospective, randomized, partly double-blind (CHOL vs PLC), partly open-label (ALFA vs CHOL or PLC) study. Out of 522 patients dialyzed in 5 centers in the Mazovian Province, 93 gave informed consent and met the inclusion criteria: vitamin D and calcimimetics naïve; no history of liver or intestinal disease; serum 25(OH)D <20 ng/ml, iPTH <1000 ->110 pg/ml, calcium <10.2 and phosphate < 6.8 mg/dl. The subjects were stratified by serum iPTH, then randomized into 3 groups according to the treatment

Results

To our knowledge, this is a first study comparing head-to-head these drugs in HD population. There were no significant differences between the groups at baseline. 81 patients completed the study.
CHOL normalized serum 25OHD, with a mean rise from 12.9±6.7 to 31.3±10.1 ng/ml (p<0.0001). This was accompanied by a marked increase of 1,25(OH)2D (from 13.8±9.3 to 25.1±14.2 pmol/l (p<0.0001). A rise in serum 1,25(OH)2 was observed also in ALFA treated patients, however much smaller (from 13.5±10.1 to 18.5±11.0 pmol/l; p=0.02). Neither CHOL nor ALFA treatment resulted in significant changes in the remaining parameters.

Conclusion

In most HD patients treatment with CHOL in a dose of 12000 IU/week permits safe correction of vitamin D deficiency and is more effective than small doses of ALFA in rising serum 1,25(OH)2D. This together with a lack of influence on circulating iPTH question the usefulness of this treatment in HD patients.