NCT01395823

Safety and Effects of Supplementation With Ergocalciferol on Erythropoietin Dosing in Hemodialysis Patients

Safety and Effects of Supplementation With Ergocalciferol on Erythropoietin Dosing in Hemodialysis Patients: A Randomized Clinical Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 470 (actual)
• Sponsor: Dialysis Clinic, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• End Stage Renal Disease

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	ergocalciferol supplementation	50,000 IU given either weekly; weekly for 3 months then monthly for 3 months; monthly
OTHER	placebo	placebo pill given weekly, weekly for 3 months then monthly for 3 months; monthly

Timeline

• Start date: 2011-06-01
• Primary completion: 2014-04-01
• Completion: 2015-06-01
• First posted: 2011-07-18
• Last updated: 2016-03-14
• Results posted: 2016-03-14

Locations

12 sites across 1 country: United States