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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Hyperphosphatemia, End-stage Renal Disease

Intervention / Treatment
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* Behavioral: Dietary education
* Behavioral: Education on phosphate binder use


Participation Criteria
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Eligibility Criteria
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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.)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>No intervention was performed | |
| Experimental: Education group<br>Dietary education and education on phosphate binder use. Pharmacists instructed patients about how to take phosphate binders properly. Dietitians educated on dietary phosphate restriction. | Behavioral: Dietary education<br> <br> Behavioral: Education on phosphate binder use<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients who reached Ca x P product lower than 55 |  | 2-3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of MMAS-8 score |  | 1 month, 2-3 month | 
| Changes of bioequivalent dose of phosphate binder |  | 2-3 month | 
| Changes of PG-SGA |  | 2-3 month | 
| Amount of change in dietary phosphorus intake |  | 2-3 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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End-stage renal disease, Phosphate binders, Hyperphosphatemia, Dietary education