跳至主要内容
临床试验/NCT02886975
NCT02886975Unknown不适用

Effects of Low Protein Diet Supplemented Keto-/Amino Acid in Preventing the Progression of Chronic Kidney Disease(CKD)

The Third Xiangya Hospital of Central South University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年8月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
changes in glomerular filtration rate

研究概览

简要总结

The purpose of this study is to determine whether low protein diet and very low protein diet supplemented keto-/amino acid is effective in preventing the progression of chronic kidney disease (CKD , stage 2 to 5).

详细描述

Dietary protein restriction represents a basic therapeutic approach in chronic kidney disease(CKD), by reducing the accumulation of nitrogen catabolic substances, and by delaying the progress of CKD and proteinuria, but the effects of the low protein diet on renal failure progression rate remain to be determined.The aim of this study is to evaluate the efficacy of low protein diet and α-keto acid tablet in retard the progress of CKD. This is a prospective study, 100 patients who meet inclusion and exclusion criteria will be included. The changes of glomerular filtration rate in CKD and time to renal replacement will be evaluated after 1 year treatment.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with chronic kidney disease in stage 2 to 5 (GFR<60 ml/min/1.73m2) receiving conservative treatment for CKD

排除标准

  • 未提供

研究组 & 干预措施

low protein diet plus α-keto acid

Experimental

A comparison of normal diet and low protein diet plus α-keto acid after intervention in the same individual

干预措施: low protein diet plus α-keto acid (Behavioral)

结局指标

主要结局

changes in glomerular filtration rate

时间窗: 1 year

Nutritional status, evaluated by nutrition risk screening (NRS 2002), at the start and during the 1st year of investigators' intervention.

次要结局

  • Compliance to diet(1 year)
  • Nutritional status(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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