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

NCT01395823 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 470

Last updated 2016-03-14

Study results available
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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

Interventions

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

Sponsors & Collaborators

  • Dialysis Clinic, Inc.

    lead INDUSTRY

Principal Investigators

  • Dana Miskulin, MD · DCI

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2014-04-30
Completion
2015-06-30

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01395823 on ClinicalTrials.gov