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Efficacy of Dietary Education and Education on Phosphate Binder Use in Hemodialysis Patients

Primary Purpose

Hyperphosphatemia, End-stage Renal Disease

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dietary education
Education on phosphate binder use
Sponsored by
Ajou University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hyperphosphatemia focused on measuring End-stage renal disease, Phosphate binders, Hyperphosphatemia, Dietary education

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • End-stage renal disease patients whose dialysis vintage is more than 3 months

Exclusion Criteria:

  • Patients with liver cirrhosis
  • Pregnant patients
  • Patients with alimentary tract malabsorption diseases
  • History of recent alcohol or drug abuse
  • Patients receiving chemotherapy for solid organ tumor
  • History of mental illness (major depressive disorder, bipolar disorder, schizophrenia, etc.)
  • Patients having difficulty communicating with our medical team (dementia, mental retardation, etc.)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Control group

    Education group

    Arm Description

    No intervention was performed

    Dietary education and education on phosphate binder use. Pharmacists instructed patients about how to take phosphate binders properly. Dietitians educated on dietary phosphate restriction.

    Outcomes

    Primary Outcome Measures

    The proportion of patients who reached Ca x P product lower than 55

    Secondary Outcome Measures

    Changes of MMAS-8 score
    Changes of bioequivalent dose of phosphate binder
    Changes of PG-SGA
    Amount of change in dietary phosphorus intake

    Full Information

    First Posted
    April 27, 2016
    Last Updated
    April 28, 2016
    Sponsor
    Ajou University School of Medicine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02755961
    Brief Title
    Efficacy of Dietary Education and Education on Phosphate Binder Use in Hemodialysis Patients
    Official Title
    A Randomized Controlled Trial to Evaluate the Efficacy of Reducing High-Phosphate Containing Diet Education and Proper Phosphate Binder Intake Education to Serum Phosphate Level Among Maintenance Hemodialysis Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2015 (undefined)
    Primary Completion Date
    October 2015 (Actual)
    Study Completion Date
    October 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ajou University School of Medicine

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Hyperphosphatemia is an independent risk factor for mortality among dialysis patients. And most phosphate in human is derived from the food. The purpose of this study is to evaluate the efficacy of nutritional consultation and education on phosphate binder among dialysis patients.
    Detailed Description
    Hyperphosphatemia is an independent risk factor for mortality among dialysis patients. Hyperphosphatemia is associated with increased incidence of cardiovascular diseases, and is a mediator to the development of hyperparathyroidism and mineral bone disorder. Phosphate is usually obtained by food intake, and it can be removed by hemodialysis. However, the efficacy of removal is limited, so that dietary education and proper intake of phosphate binder is essential.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hyperphosphatemia, End-stage Renal Disease
    Keywords
    End-stage renal disease, Phosphate binders, Hyperphosphatemia, Dietary education

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    70 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    No intervention was performed
    Arm Title
    Education group
    Arm Type
    Experimental
    Arm Description
    Dietary education and education on phosphate binder use. Pharmacists instructed patients about how to take phosphate binders properly. Dietitians educated on dietary phosphate restriction.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Dietary education
    Intervention Type
    Behavioral
    Intervention Name(s)
    Education on phosphate binder use
    Primary Outcome Measure Information:
    Title
    The proportion of patients who reached Ca x P product lower than 55
    Time Frame
    2-3 month
    Secondary Outcome Measure Information:
    Title
    Changes of MMAS-8 score
    Time Frame
    1 month, 2-3 month
    Title
    Changes of bioequivalent dose of phosphate binder
    Time Frame
    2-3 month
    Title
    Changes of PG-SGA
    Time Frame
    2-3 month
    Title
    Amount of change in dietary phosphorus intake
    Time Frame
    2-3 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: End-stage renal disease patients whose dialysis vintage is more than 3 months Exclusion Criteria: Patients with liver cirrhosis Pregnant patients Patients with alimentary tract malabsorption diseases History of recent alcohol or drug abuse Patients receiving chemotherapy for solid organ tumor History of mental illness (major depressive disorder, bipolar disorder, schizophrenia, etc.) Patients having difficulty communicating with our medical team (dementia, mental retardation, etc.)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jong Cheol Jeong, MD
    Organizational Affiliation
    Clinical Assistant Professor
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Efficacy of Dietary Education and Education on Phosphate Binder Use in Hemodialysis Patients

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