Back to resultsEfficacy 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
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
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
NCT ID
NCT02755961
First Posted
April 27, 2016
Last Updated
April 28, 2016
Sponsor
Ajou University School of Medicine
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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