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type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/advagg_css\/css__ce2QY63WIanKyr8eSq7eavr1XQRRmFD6ZSmwpyJi8lM__zXwFqpqmxrZOXXcd_TpBQpjuELbmIP9wBR5UuTDWAO4__YJWWMMdfCJuAFm5cUEp88OsodhO3ZA-2lzRfoBsSlk4.css\u0022 media=\u0022all\u0022 \/\u003E\n\u003Clink rel=\u0027stylesheet\u0027 type=\u0027text\/css\u0027 href=\u0027\/sites\/all\/modules\/contrib\/panels\/plugins\/layouts\/onecol\/onecol.css\u0027 \/\u003E\u003C\/head\u003E\u003Cbody\u003E\u003Cdiv class=\u0022panels-ajax-tab-panel panels-ajax-tab-panel-sageoa-tab-art\u0022\u003E\u003Cdiv class=\u0022panel-display panel-1col clearfix\u0022 \u003E\n  \u003Cdiv class=\u0022panel-panel panel-col\u0022\u003E\n    \u003Cdiv\u003E\u003Cdiv class=\u0022panel-pane pane-highwire-markup\u0022 \u003E\n  \n      \n  \n  \u003Cdiv class=\u0022pane-content\u0022\u003E\n    \u003Cdiv class=\u0022highwire-markup\u0022\u003E\u003Cdiv xmlns=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022 id=\u0022content-block-markup\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cdiv class=\u0022article fulltext-view \u0022\u003E\u003Cspan class=\u0022highwire-journal-article-marker-start\u0022\u003E\u003C\/span\u003E\u003Cdiv class=\u0022section abstract\u0022 id=\u0022abstract-1\u0022\u003E\u003Ch2\u003ESummary\u003C\/h2\u003E\n            \u003Cp id=\u0022p-1\u0022\u003EVitamin D deficiency has been linked to cardiovascular events and mortality, infection, and autoimmune disorders. Deficiency of 25-hydroxyvitamin D [25(OH)D] \u0026lt;30 ng\/mL occurs in about 80% of patients undergoing dialysis. The double-blind, placebo-controlled Safety and Effects of Supplementation With Ergocalciferol on Erythropoietin Dosing in Hemodialysis Patients [\u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01395823\u0026amp;atom=%2Fspmdc%2F14%2F49%2F11.atom\u0022\u003ENCT01395823\u003C\/a\u003E] trial investigated the safety and effects of dosing on dialysis patients, as discussed in this article.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003ENephrology Clinical Trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ETreatments\u003C\/li\u003E\u003C\/ul\u003E\u003Cul class=\u0022kwd-group clinical-trial\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003ENephrology Clinical Trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ENephrology\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ETreatments\u003C\/li\u003E\u003C\/ul\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-1\u0022\u003E\n         \n         \u003Cp id=\u0022p-2\u0022\u003EVitamin D deficiency has been linked to cardiovascular events and mortality, infection, and autoimmune disorders [Nigwekar SU et al. \u003Cem\u003EAm J Kidney Dis.\u003C\/em\u003E 2012]. Deficiency of 25-hydroxyvitamin D [25(OH)D] \u0026lt; 30 ng\/mL occurs in about 80% of patients undergoing dialysis. Retrospective observational studies in dialysis have shown mixed results of 25(OH)D supplementation on parathyroid hormone (PTH) and erythropoiesis-stimulating agent use. Clinical trials of 25(OH)D supplementation showed mixed results, were limited by small numbers of patients, and showed no effect on outcomes.\u003C\/p\u003E\n         \u003Cp id=\u0022p-3\u0022\u003EDana C. Miskulin, MD, Tufts Medical Center, Boston, Massachusetts, USA, reported on Safety and Effects of Supplementation With Ergocalciferol on Erythropoietin Dosing in Hemodialysis Patients [\u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01395823\u0026amp;atom=%2Fspmdc%2F14%2F49%2F11.atom\u0022\u003ENCT01395823\u003C\/a\u003E], a double-blind, placebo-controlled trial to confirm safety and determine the effects of dosing on dialysis patients.\u003C\/p\u003E\n         \u003Cp id=\u0022p-4\u0022\u003EPatients who were receiving dialysis, on a stable erythropoietin (EPO) dose, with no impairment to oral 25(OH)D absorption, and deficient in 25(OH)D (\u0026lt; 30 ng\/mL) were eligible. Ergocalciferol doses were determined using baseline 25(OH)D levels.\u003C\/p\u003E\n         \u003Cp id=\u0022p-5\u0022\u003EStudy outcomes included changes in doses of EPO, 1,25(OH)2D, and phosphate binders; changes in levels of calcium, phosphorous, PTH, and C-reactive protein (CRP); use of cinacalcet; and incidence of hypercalcemia or hyperphosphatemia, all-cause hospitalization, infectious hospitalization, total infections, falls, and fractures.\u003C\/p\u003E\n         \u003Cp id=\u0022p-6\u0022\u003EEligible patients with baseline 25(OH)D \u0026lt; 30 ng\/mL (n = 276) were randomly assigned to placebo (n = 139) or ergocalciferol (n = 137). In both the treatment and placebo groups, there were 4 deaths and 15 patients dropped out. The 2 groups were well balanced for demographic characteristics, including age (median 61 years), sex, race, 25(OH)D levels and dose, and EPO dose; about 80% were taking active vitamin D.\u003C\/p\u003E\n         \u003Cp id=\u0022p-7\u0022\u003EMean 25(OH)D levels increased to 40 ng\/mL at 3 months and to 38 ng\/mL at 6 months in the ergocalciferol group compared with the placebo group (\u003Cem\u003EP\u003C\/em\u003E \u0026lt; .0001). For patients with a baseline 25(OH)D of 16 to 30 ng\/mL, there was an increase at 3 months but a decline at 6 months; however, 25(OH)D levels remained significantly increased (\u003Cem\u003EP\u003C\/em\u003E \u0026lt; .0001).\u003C\/p\u003E\n         \u003Cp id=\u0022p-8\u0022\u003EThere was no significant difference (\u003Cem\u003EP\u003C\/em\u003E = .76) between placebo and ergocalciferol in the change in EPO dose or change in PTH (\u003Cem\u003EP\u003C\/em\u003E = .60). In addition, there were no significant changes in calcium, phosphorous, calcitriol dose, phosphate binder use, cinacalcet use, or CRP levels or significant differences between groups in all-cause hospitalization, cardiovascular hospitalization, infectious hospitalization, total infections, falls, and fracture events.\u003C\/p\u003E\n         \u003Cp id=\u0022p-9\u0022\u003EThe only significant difference between groups was in doxercalciferol; the change in micrograms\/treatment\/month for the ergocalciferol group was 0.21 (95% CI, 0.10 to 0.31) and for the placebo group was 0.04 (\u22120.06 to 0.15; \u003Cem\u003EP\u003C\/em\u003E = .02). However, Dr Miskulin did not consider this to be clinically significant.\u003C\/p\u003E\n         \u003Cp id=\u0022p-10\u0022\u003EAlthough it was the largest randomized controlled trial of vitamin D supplementation in patients on dialysis, this study was subject to limitations, including a high percentage of black patients (n = 160), who have lower total 25(OH)D levels than whites [Powe CE et al. \u003Cem\u003EN Engl J Med.\u003C\/em\u003E 2013], although in a subgroup analysis, no differences by race were found for any outcome.\u003C\/p\u003E\n         \u003Cp id=\u0022p-11\u0022\u003ESupplementation with 25(OH)D to achieve levels \u2265 30 ng\/mL in patients on dialysis is safe, but in this short, underpowered study, it does not appear to offer any benefits.\u003C\/p\u003E\n      \u003C\/div\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2015 MD Conference Express\u00ae\u003C\/li\u003E\u003C\/ul\u003E\u003Cspan class=\u0022highwire-journal-article-marker-end\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Cspan id=\u0022related-urls\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Ca href=\u0022http:\/\/mdc.sagepub.com\/content\/14\/49\/11.abstract\u0022 class=\u0022hw-link hw-link-article-abstract\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView Summary\u003C\/a\u003E\u003C\/div\u003E  \u003C\/div\u003E\n\n  \n  \u003C\/div\u003E\n\u003C\/div\u003E\n  \u003C\/div\u003E\n\u003C\/div\u003E\n\u003C\/div\u003E\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_openurl.js?nzltsp\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}