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

NCT ID: NCT02886975

Last Updated: 2019-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2019-12-31

Brief Summary

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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

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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.

Conditions

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Renal Insufficiency, Chronic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

low protein diet plus α-keto acid

Intervention Type BEHAVIORAL

0.4-0.6g of proteins per kilo of body weight per day, supplemented with α-keto acid tablets

Interventions

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low protein diet plus α-keto acid

0.4-0.6g of proteins per kilo of body weight per day, supplemented with α-keto acid tablets

Intervention Type BEHAVIORAL

Other Intervention Names

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low protein diet

Eligibility Criteria

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Inclusion Criteria

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Third Xiangya Hospital of Central South University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Min Liu, M.D.

Role: STUDY_DIRECTOR

specify unaffiliated

Locations

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the Third Xiangya Hospital of Central South University

Changsha, Hu'nan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Min Liu, M.D.

Role: CONTACT

86-731-88618717

Meng Wang, M.M.

Role: CONTACT

86-731-88618717

Facility Contacts

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Min Liu, M.D.

Role: primary

86-731-88618717

Meng Wang, M.M.

Role: backup

86-731-88618717

Other Identifiers

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YYK-2016001

Identifier Type: -

Identifier Source: org_study_id

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