Effects of Ergocalciferol on Erythropoetin Stimulating Agent Dose (EASY)

March 10, 2015 updated by: Kaiser Permanente
Hypothesis: The supplementation of Ergocalciferol (Vitamin D2) to those with Vitamin D deficiency in the Chronic Kidney Disease population requiring recombinant human erythropoietin for the treatment of anemia related to kidney disease will reduce the dose of erythropoietin required to maintain a nonanemic state.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90027
        • Kaiser Permanente Los Angeles Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Chronic kidney disease
  • Age: >18yo
  • Stable Hemoglobin (Hgb) for 1 month on stable dose of erythropoietin for 1 month (defined as erythropoietin dose within 15% of previous months erythropoietin dose)
  • Unchanged maintenance oral or intravenous (IV) iron therapy for 1 month
  • Serum 25-hydroxy Vitamin D levels < 30 ng/mL
  • History of 25-hydroxy Vitamin D levels < 30 ng/mL currently on ergocalciferol replacement

Exclusion Criteria:

  • On hemodialysis
  • Chronic kidney disease 5
  • Hypercalcemic (Calcium level > 11mg/dL)
  • Pregnant female
  • Iron deficient (iron saturation < 20%, Ferritin < 100ng/mL)
  • Presence of active malignancy
  • Presence of active infections
  • Presence of active inflammatory properties
  • Presence of blood dyscrasias
  • Active bleeding or bleeding within the past 3 months (other than menses)
  • B12 deficiency
  • Folate deficiency
  • Blood transfusion during participation
  • Parathyroid levels exceeding the expected levels allowed for the stage of a subjects Chronic kidney disease (Target Parathyroid in: Chronic kidney disease 3 35-70 pg/mL, Chronic kidney disease 4 70-110 pg/mL)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ergocalciferol supplementation
Drug: Ergocalciferol supplementation
Vitamin D in the form of ergocalciferol will be the drug utilized in the study. This medication is a Vitamin D analog and is normally used in the current study population to help augment those who are deficient in Vitamin D.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluate if Ergocalciferol Supplementation to Achieve 25-hydroxy Vitamin D Levels > 40ng/ml Will Decrease Erythropoietin Requirements
Time Frame: 24 Weeks
24 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Inflammatory Markers
Time Frame: 24 Weeks
24 Weeks
Change in Calcium, Phosphorous,Calcium x Phosphorous Product, and Parathyroid Hormone Levels
Time Frame: 24 Weeks
24 Weeks
Change in Iron Supplementation
Time Frame: 24 Weeks
24 Weeks
Change in Erythropoietin Adjusted for Change in Inflammatory Markers, Vitamin D Levels and Clinical and Demographic Confounders
Time Frame: 24 Weeks
24 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaiser Permanente

Investigators

  • Principal Investigator: John J Sim, MD, Kaiser Permanente

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

December 16, 2010

First Submitted That Met QC Criteria

December 16, 2010

First Posted (Estimate)

December 20, 2010

Study Record Updates

Last Update Posted (Estimate)

March 30, 2015

Last Update Submitted That Met QC Criteria

March 10, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIM2010001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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