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

Not Applicable

Completed

• Conditions: End-stage Renal Disease; Hyperphosphatemia
• Interventions: Behavioral: Dietary education; Behavioral: Education on phosphate binder use

• Registration Number: NCT02755961
• Lead Sponsor: Ajou University School of Medicine

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.

Study Timeline

• Study Start: 2015-07
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2016-04
• Study First Submitted: 2016-04-27
• Study First Submitted QC: 2016-04-28
• Last Update Submitted: 2016-04-28
• Study First Posted: 2016-04-29
• Last Update Posted: 2016-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
The proportion of patients who reached Ca x P product lower than 55	2-3 month

Secondary Outcome Measures

Name	Time	Method
Changes of PG-SGA	2-3 month
Changes of bioequivalent dose of phosphate binder	2-3 month
Changes of MMAS-8 score	1 month, 2-3 month
Amount of change in dietary phosphorus intake	2-3 month