A few studies have reported erythropoiesis-stimulating agent (ESA) doses before and after 25D supplementation, but only one of these is a prospective clinical trial, and it is a small, single center study lacking a control arm. The investigators propose to conduct a double blind, randomized, placebo controlled clinical trial of ergocalciferol supplementation to confirm safety and determine effects on Erythropoietin (EPO) dosing, active D dosing, and mineral metabolic parameters in hemodialysis patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
470
50,000 IU given either weekly; weekly for 3 months then monthly for 3 months; monthly
placebo pill given weekly, weekly for 3 months then monthly for 3 months; monthly
DCI - Redding
Redding, California, United States
DCI - Albany
Albany, Georgia, United States
DCI - Shreveport
Shreveport, Louisiana, United States
EPO Dose
The primary outcome is the change in the median EPO dose from baseline to 6 months after ergocalciferol supplementation.
Time frame: Baseline, 6 months
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DCI - Boston
Boston, Massachusetts, United States
DCI- Columbia
Columbia, Missouri, United States
DCI - Kansas City
Kansas City, Missouri, United States
DCI- Omaha
Omaha, Nebraska, United States
DCI - New Brunswick
New Brunswick, New Jersey, United States
DCI - North Brunswick
North Brunswick, New Jersey, United States
DCI - Philadelphia
Philadelphia, Pennsylvania, United States
...and 2 more locations