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

February 15, 2016 updated by: Dialysis Clinic, Inc.

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
470

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

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
      • Redding, California, United States, 96003
        • DCI - Redding
    • Georgia
      • Albany, Georgia, United States, 31701
        • DCI - Albany
    • Louisiana
      • Shreveport, Louisiana, United States, 71103
        • DCI - Shreveport
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • DCI - Boston
    • Missouri
      • Columbia, Missouri, United States, 65201
        • DCI- Columbia
      • Kansas City, Missouri, United States, 64131
        • DCI - Kansas City
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • DCI- Omaha
    • New Jersey
      • New Brunswick, New Jersey, United States, 08903
        • DCI - New Brunswick
      • North Brunswick, New Jersey, United States, 08902
        • DCI - North Brunswick
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19129
        • DCI - Philadelphia
    • Tennessee
      • Knoxville, Tennessee, United States, 37924
        • DCI - Knoxville
      • Maryville, Tennessee, United States, 37804
        • DCI - Maryville

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients treated with thrice weekly in-center hemodialysis (HD) for more than 90 days.
  2. Treated with EPO for at least 90 days. The mode of administration, intravenous (IV) or subcutaneous (SC), must remain the same for 90 days prior to enrollment.
  3. The method by which EPO is prescribed (per DCI Corporate or local protocol or per physician on an individualized basis) must remain the same for at least 90 days prior to enrollment with respect to the ceiling for the total EPO dose administered per week, if a ceiling is used, and the level of hemoglobin (Hgb) at which EPO is discontinued (Hgb cutoff), if a Hgb cutoff is used.
  4. The method by which IV Iron is prescribed (per DCI Corporate or local protocol or per physician on an individualized basis) must remain the same for at least 90 days prior to enrollment with respect to the serum ferritin and transferrin saturation (TSAT) targeted, if specific ferritin and TSAT targets are used

Exclusion Criteria:

  1. Patients with a serum calcium ≥10.5 mg/dL on at least one occasion in the past 30 days.
  2. Patients with a serum phosphorus >8.0 mg/dL on at least one occasion in the past 30 days.
  3. Active infection defined by the use of IV antibiotic use within the past 30 days.
  4. Current use of immunosuppressant medications other than low dose corticosteroids (prednisone <10 mg per day or equivalent)
  5. History of a hematological malignancy (e.g. multiple myeloma, leukemia).
  6. Sickle cell disease (sickle cell trait is not an exclusion).
  7. Myelodysplasia requiring 1 or more blood transfusions in the past 3 months.
  8. Transfusion for any reason within the past 30 days.
  9. Medical conditions that cause a reduction in the absorption of oral vitamin D including Crohn's disease, celiac sprue, cystic fibrosis and surgical removal of part or all of the stomach or intestine.
  10. Medications that cause a reduction in the absorption of oral vitamin D including cholestyramine (Questran, others), colestipol (Colestid, others) and orlistat (Xenical, Alli).
  11. Known allergy/adverse reaction to ergocalciferol.
  12. Treated with ergocalciferol and/or cholecalciferol (except if part of a multi-vitamin) within the last 3 months.
  13. Average Kt/V < 1.3 on past three monthly labs. There must be at least 2 monthly Kt/V values in the past three months.
  14. Skipped more than 3 dialysis treatments (excluding planned missed treatments) within the past 3 months for reasons other than hospitalization.
  15. Life expectancy less than 6 months.
  16. Kidney transplantation planned in the next 6 months.
  17. Switch to peritoneal dialysis planned in the next 6 months.
  18. Pregnant or planning to become pregnant within the next 6 months. A pre-menopausal woman must agree to use contraception for the duration of the study. If a woman has not had menses in over 12 months, consider this patient to be menopausal.
  19. Unable or unwilling to give informed consent.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: placebo
Other: placebo
placebo pill given weekly, weekly for 3 months then monthly for 3 months; monthly
Other Names:
  • sugar pill
Other: ergocalciferol supplementation
Dietary supplement: ergocalciferol supplementation
50,000 IU given either weekly; weekly for 3 months then monthly for 3 months; monthly
Other Names:
  • vitamin D, D2

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
EPO Dose
Time Frame: Baseline, 6 months
The primary outcome is the change in the median EPO dose from baseline to 6 months after ergocalciferol supplementation.
Baseline, 6 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dialysis Clinic, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dana Miskulin, MD, DCI

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 14, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 18, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 14, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DCI-0002

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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