title: 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 D may 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 serum 25(OH)D <30 ng/ml. In all, 276 patients were randomized to 6 months of ergocalciferol or placebo. Mean±SD serum 25(OH)D increased from 16.0±5.9 ng/ml at baseline to 39.2±14.9 ng/ml in the ergocalciferol arm and did not change (16.9±6.4 ng/ml and 17.5±7.4 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 power was limited for these outcomes. In conclusion, 6 months 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.
authors.affiliation: Division of Nephrology, and Tufts University School of Medicine, Boston, Massachusetts; dmiskulin@tuftsmedicalcenter.org.
authors.forename: Dana C
authors.initials: DC
authors.lastname: Miskulin
authors.affiliation: Dialysis Clinic Inc., Nashville, Tennessee;
authors.forename: Karen
authors.initials: K
authors.lastname: Majchrzak
authors.affiliation: Tufts University School of Medicine, Boston, Massachusetts; Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, Massachusetts;
authors.forename: Hocine
authors.initials: H
authors.lastname: Tighiouart
authors.affiliation: Kidney Associates of Kansas City, Kansas City, Missouri;
authors.forename: Richard S
authors.initials: RS
authors.lastname: Muther
authors.affiliation: Dialysis Clinic Inc., North Brunswick, New Jersey; and Rutgers-Robert Wood Johnson Medical School, New Brunswick, New Jersey.
authors.forename: Toros
authors.initials: T
authors.lastname: Kapoian
authors.affiliation: Dialysis Clinic Inc., Nashville, Tennessee;
authors.forename: Doug S
authors.initials: DS
authors.lastname: Johnson
authors.affiliation: Division of Nephrology, and Tufts University School of Medicine, Boston, Massachusetts;
authors.forename: Daniel E
authors.initials: DE
authors.lastname: Weiner
mesh_terms: D019587:Dietary Supplements; D004311:Double-Blind Method; D004872:Ergocalciferols / Q000627:therapeutic use*; D006801:Humans; D008875:Middle Aged; D006435:Renal Dialysis; D014808:Vitamin D Deficiency / Q000188:drug therapy*; D014815:Vitamins / Q000627:therapeutic use*
chemical_list: D004872:Ergocalciferols; D014815:Vitamins
keywords: anemia; hyperparathyroidism; randomized controlled trials; vitamin D