Ergocalciferol supplementation in hemodialysis patients with Vitamin D deficiency: A randomized clinical trial

Abstract

Locally produced 1,25-dihydroxyvitamin D3 may have pleiotropic effects outside of bone. Experimental and observational studies suggest that nutritional vitamin Dmay enhance erythropoiesis in settings of 25- hydroxy vitamin D (25(OH)D) deficiency. We conducted a double-blind, placebo-controlled, randomized clinical trial to assess the effects of supplementation with ergocalciferol on epoetin utilization and other secondary outcomes in patients on hemodialysis with serum25(OH)D ,30 ng/ml. In all, 276 patients were randomized to 6months of ergocalciferol or placebo.Mean6SD serum 25(OH)D increased from16.065.9 ng/ml at baseline to 39.2614.9 ng/ml in the ergocalciferol arm and did not change (16.966.4 ng/ml and 17.567.4 ng/ml, respectively) in the placebo arm. There was no significant change in epoetin dose over 6 months in the ergocalciferol or placebo arms (geometric mean rate 0.98 [95% confidence interval (95%CI), 0.94 to 1.02] versus 0.99 [95% CI, 0.95 to 1.03], respectively) and no difference across arms (P=0.78). No change occurred in serum calcium, phosphorus, intact parathyroid hormone, or C-reactive protein levels, cinacalcet use, or phosphate binder or calcitriol dose in either study arm. Rates of all-cause, cardiovascular, and infection-related hospitalizations did not differ by study arm, although statistical powerwas limited for these outcomes. In conclusion, 6months of supplementation with ergocalciferol increased serum 25(OH)D levels in patients on hemodialysis with vitamin D insufficiency or deficiency, but had no effect on epoetin utilization or secondary biochemical and clinical outcomes.