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NCT02886975 Clinical Trial

Effects of Low Protein Diet in Preventing the Progression of Chronic Kidney Disease(CKD)---a Prospective Study

Renal Insufficiency, Chronic Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02886975
Other study ID # YYK-2016001
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 2016
Est. completion date December 2019

Study information
Verified date April 2019
Source The Third Xiangya Hospital of Central South University
Contact Min Liu, M.D.
Phone 86-731-88618717
Email liumin330@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date December 2019
Est. primary completion date December 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: Patients with chronic kidney disease in stage 2 to 5 (GFR<60 ml/min/1.73m2) receiving conservative treatment for CKD

Exclusion Criteria: None

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• low protein diet plus a-keto acid
0.4-0.6g of proteins per kilo of body weight per day, supplemented with a-keto acid tablets

Locations
Country Name City State
China the Third Xiangya Hospital of Central South University Changsha Hunan

Sponsors (1)
Lead Sponsor Collaborator
The Third Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary changes in glomerular filtration rate Nutritional status, evaluated by nutrition risk screening (NRS 2002), at the start and during the 1st year of investigators' intervention. 1 year
Secondary Compliance to diet Compliance to diet, defined by the participants' persistence in low protein diet, by outpatient follow-up and telephone follow-up. 1 year
Secondary Nutritional status Nutritional status, evaluated by nutrition risk screening (NRS 2002), at the start and during the 1st year of investigators' intervention. 1 year
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