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

April 28, 2016 updated by: Jong Cheol Jeong, Ajou University School of Medicine

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
No intervention was performed
Experimental: Education group
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
Behavioral: Education on phosphate binder use

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Ajou University School of Medicine

Investigators

  • Principal Investigator: Jong Cheol Jeong, MD, Clinical Assistant Professor

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

July 1, 2015

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

April 27, 2016

First Submitted That Met QC Criteria

April 28, 2016

First Posted (Estimate)

April 29, 2016

Study Record Updates

Last Update Posted (Estimate)

April 29, 2016

Last Update Submitted That Met QC Criteria

April 28, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MED-SUR-15-147

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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