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

Not Applicable

• Conditions: Renal Insufficiency, Chronic
• Interventions: Behavioral: low protein diet plus α-keto acid

• Registration Number: NCT02886975
• Lead Sponsor: The Third Xiangya Hospital of Central South University

Brief 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).

Detailed 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.

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-08-07
• Study First Submitted QC: 2016-08-26
• Study First Posted: 2016-09-01
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-17
• Last Update Posted: 2019-04-19
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
changes in glomerular filtration rate	1 year	Nutritional status, evaluated by nutrition risk screening (NRS 2002), at the start and during the 1st year of investigators' intervention.

Secondary Outcome Measures

Name	Time	Method
Compliance to diet	1 year	Compliance to diet, defined by the participants' persistence in low protein diet, by outpatient follow-up and telephone follow-up.
Nutritional status	1 year	Nutritional status, evaluated by nutrition risk screening (NRS 2002), at the start and during the 1st year of investigators' intervention.

Trial Locations

Locations (1)

the Third Xiangya Hospital of Central South University; 🇨🇳 Changsha, Hunan, China