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Completed

NCT Number: NCT02755961

Efficacy of Dietary Education and Education on Phosphate Binder Use in 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.

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Key information

Conditions

Hyperphosphatemia Chronic Disease Disease Attributes End-stage Renal Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Phosphorus Metabolism Disorders Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Dietary Education

Behavioral

Education on phosphate binder use

Behavioral

Primary outcomes

  1. The proportion of patients who reached Ca x P product lower than 55

    Time frame: 2-3 month

Secondary outcomes

  1. Changes of MMAS-8 score

    Time frame: 1 month, 2-3 month

  2. Changes of bioequivalent dose of phosphate binder

    Time frame: 2-3 month

  3. Changes of PG-SGA

    Time frame: 2-3 month

  4. Amount of change in dietary phosphorus intake

    Time frame: 2-3 month

Sponsors and collaborators

Lead sponsor

Ajou University School of Medicine

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Apr 29, 2016
Registry last updated
Apr 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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