In the Journals

Vitamin D supplementation did not treat anemia in patients on dialysis

Results from a clinical trial indicate that nutritional vitamin D supplements do not help in treating anemia in patients on hemodialysis, according to data published in the Journal of the American Society of Nephrology.

Dana C. Miskulin , MD, MS, a nephrologist and associate professor at Tufts University School of Medicine, and colleagues conducted a double-masked, placebo-controlled, randomized clinical trial to investigate the effects of supplementation.

"Most patients on dialysis are treated with vitamin D receptor agonists (VDRAs), such as calcitrol, doxercalciferol or paracalcitol, for management of secondary hyperparathyroidism; however, if the hypothesized pleiotropic effects of vitamin D require local production, supplementation with VDRAs without its nutritional vitamin D precursor may not optimize clinical benefits, particularly as more than half of patients on hemodialysis are deficient in total serum 25-hydroxy vitamin D [25(OH)D]," Miskulin and colleagues wrote. "The 2009 Kidney Disease: Improving Global Outcomes Chronic Kidney Disease-Mineral and Bone Disorder clinical guideline suggest supplementing with nutritional vitamin D to achieve 25(OH)D 30 ng/ml in patients on hemodialysis."

The researchers randomly assigned 276 patients with 25(OH)D levels of 30 ng/ml or less at baseline to treatment with ergocalciferol or placebo for 6 months.

Results showed that participants in the ergocalciferol group had a mean 25(OH)D baseline level of 16±5.9 ng/ml, which increased to 41±15.6 ng/ml at 3 months and 39.2±14.9 ng/ml at 6 months. Participants in the placebo group had a mean 25(OH)D baseline level of 16.9±6.4 ng/ml, which did not change with levels of 17.3±7 ng/ml at 3 months and 17.5±7.4 ng/ml at 6 months. Additionally, there was no change in weekly epoetin dose in the ergocalciferol group (geometric mean rate = 0.98; 95% CI, 0.94-1.02) or the placebo (geometric mean rate = 0.99; 95% CI, 0.95-1.03) and no difference in the rate of change across the groups (P = .78).

There were no recorded changes in intact parathyroid hormone, phosphorus, serum calcium or C-reactive protein levels, phosphate binder or calcitriol dose or cinalcalet use in either treatment group.

Miskulin and colleagues also reported similar rates of call-cause, cardiovascular or infectious hospitalizations, falls and fractures between the treatment groups.

"Administration of ergocalciferol to 25(OH)D-deficient patients on hemodialysis increased 25(OH)D levels without significant increases in serum calcium or phosphorus; however, treatment had no effect on the primary outcome of epoetin dose," Miskulin and colleagues wrote. "While the study was not designed to examine all postulated actions that nutritional vitamin D might have, and thus, we cannot conclude that nutritional vitamin D is of no value in patients on dialysis, the study design was sufficient for us to conclude that there is no role for nutritional vitamin D in the management of anemia in patients on hemodialysis." by Chelsea Frajerman Pardes

Disclosures: All authors are either employed by Dialysis Clinic Inc. (DCI), receive salary support from DCI or are DCI medical directors. The authors report no additional financial disclosures.

Results from a clinical trial indicate that nutritional vitamin D supplements do not help in treating anemia in patients on hemodialysis, according to data published in the Journal of the American Society of Nephrology.

Dana C. Miskulin , MD, MS, a nephrologist and associate professor at Tufts University School of Medicine, and colleagues conducted a double-masked, placebo-controlled, randomized clinical trial to investigate the effects of supplementation.

"Most patients on dialysis are treated with vitamin D receptor agonists (VDRAs), such as calcitrol, doxercalciferol or paracalcitol, for management of secondary hyperparathyroidism; however, if the hypothesized pleiotropic effects of vitamin D require local production, supplementation with VDRAs without its nutritional vitamin D precursor may not optimize clinical benefits, particularly as more than half of patients on hemodialysis are deficient in total serum 25-hydroxy vitamin D [25(OH)D]," Miskulin and colleagues wrote. "The 2009 Kidney Disease: Improving Global Outcomes Chronic Kidney Disease-Mineral and Bone Disorder clinical guideline suggest supplementing with nutritional vitamin D to achieve 25(OH)D 30 ng/ml in patients on hemodialysis."

The researchers randomly assigned 276 patients with 25(OH)D levels of 30 ng/ml or less at baseline to treatment with ergocalciferol or placebo for 6 months.

Results showed that participants in the ergocalciferol group had a mean 25(OH)D baseline level of 16±5.9 ng/ml, which increased to 41±15.6 ng/ml at 3 months and 39.2±14.9 ng/ml at 6 months. Participants in the placebo group had a mean 25(OH)D baseline level of 16.9±6.4 ng/ml, which did not change with levels of 17.3±7 ng/ml at 3 months and 17.5±7.4 ng/ml at 6 months. Additionally, there was no change in weekly epoetin dose in the ergocalciferol group (geometric mean rate = 0.98; 95% CI, 0.94-1.02) or the placebo (geometric mean rate = 0.99; 95% CI, 0.95-1.03) and no difference in the rate of change across the groups (P = .78).

There were no recorded changes in intact parathyroid hormone, phosphorus, serum calcium or C-reactive protein levels, phosphate binder or calcitriol dose or cinalcalet use in either treatment group.

Miskulin and colleagues also reported similar rates of call-cause, cardiovascular or infectious hospitalizations, falls and fractures between the treatment groups.

"Administration of ergocalciferol to 25(OH)D-deficient patients on hemodialysis increased 25(OH)D levels without significant increases in serum calcium or phosphorus; however, treatment had no effect on the primary outcome of epoetin dose," Miskulin and colleagues wrote. "While the study was not designed to examine all postulated actions that nutritional vitamin D might have, and thus, we cannot conclude that nutritional vitamin D is of no value in patients on dialysis, the study design was sufficient for us to conclude that there is no role for nutritional vitamin D in the management of anemia in patients on hemodialysis." by Chelsea Frajerman Pardes

Disclosures: All authors are either employed by Dialysis Clinic Inc. (DCI), receive salary support from DCI or are DCI medical directors. The authors report no additional financial disclosures.