跳至主要内容
临床试验/NCT02755961
NCT02755961已完成不适用

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

Ajou University School of Medicine0 个研究点目标入组 70 人开始时间: 2015年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
70
主要终点
The proportion of patients who reached Ca x P product lower than 55

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • End-stage renal disease patients whose dialysis vintage is more than 3 months

排除标准

  • 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.)

结局指标

主要结局

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

时间窗: 2-3 month

次要结局

  • 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)
  • Changes of PG-SGA(2-3 month)

研究者

发起方
Ajou University School of Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jong Cheol Jeong

Clinical Assistant Professor

Ajou University School of Medicine

相似试验