CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 470 enrolled
Drug / intervention
ergocalciferol supplementation +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01395823
NCT01395823Phase 4Completed
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Safety and Effects of Supplementation With Ergocalciferol on Erythropoietin Dosing in Hemodialysis Patients: A Randomized Clinical Trial

Dialysis Clinic, Inc.·interventional·Posted Jul 18, 2011·Updated Mar 14, 2016

In Brief

A Phase 4 clinical trial evaluating ergocalciferol supplementation and placebo for End Stage Renal Disease. Completed, enrolled 470 participants across 12 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEnd Stage Renal Disease
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 18, 2011
Enrollment StartJun 1, 2011
Primary CompletionApr 1, 2014
Study CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 15.0 years ago

Interventions

ergocalciferol supplementationdietary

50,000 IU given either weekly; weekly for 3 months then monthly for 3 months; monthly

placeboother

placebo pill given weekly, weekly for 3 months then monthly for 3 months; monthly