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

End-stage Renal Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02755961
• Other study ID #: MED-SUR-15-147
• Status: Completed
• Phase: N/A
• First received: April 27, 2016
• Last updated: April 28, 2016
• Start date: July 2015
• Est. completion date: October 2015

Study information

• Verified date: April 2016
• Source: Ajou University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• End-stage Renal Disease
• Hyperphosphatemia
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Behavioral:
• Dietary education

• Education on phosphate binder use

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ajou University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of patients who reached Ca x P product lower than 55		2-3 month	No
Secondary	Changes of MMAS-8 score		1 month, 2-3 month	No
Secondary	Changes of bioequivalent dose of phosphate binder		2-3 month	No
Secondary	Changes of PG-SGA		2-3 month	No
Secondary	Amount of change in dietary phosphorus intake		2-3 month	No