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

Primary Purpose

Renal Insufficiency, Chronic

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
low protein diet plus α-keto acid
Sponsored by
The Third Xiangya Hospital of Central South University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Insufficiency, Chronic focused on measuring Renal Insufficiency, Chronic, Diet, Protein-Restricted

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • the Third Xiangya Hospital of Central South UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

low protein diet plus α-keto acid

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
August 7, 2016
Last Updated
April 17, 2019
Sponsor
The Third Xiangya Hospital of Central South University
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1. Study Identification

Unique Protocol Identification Number
NCT02886975
Brief Title
Effects of Low Protein Diet in Preventing the Progression of Chronic Kidney Disease(CKD)---a Prospective Study
Official Title
Effects of Low Protein Diet Supplemented Keto-/Amino Acid in Preventing the Progression of Chronic Kidney Disease(CKD)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (undefined)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Third Xiangya Hospital of Central South University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Insufficiency, Chronic
Keywords
Renal Insufficiency, Chronic, Diet, Protein-Restricted

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
low protein diet plus α-keto acid
Arm Type
Experimental
Arm Description
A comparison of normal diet and low protein diet plus α-keto acid after intervention in the same individual
Intervention Type
Behavioral
Intervention Name(s)
low protein diet plus α-keto acid
Other Intervention Name(s)
low protein diet
Intervention Description
0.4-0.6g of proteins per kilo of body weight per day, supplemented with α-keto acid tablets
Primary Outcome Measure Information:
Title
changes in glomerular filtration rate
Description
Nutritional status, evaluated by nutrition risk screening (NRS 2002), at the start and during the 1st year of investigators' intervention.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Compliance to diet
Description
Compliance to diet, defined by the participants' persistence in low protein diet, by outpatient follow-up and telephone follow-up.
Time Frame
1 year
Title
Nutritional status
Description
Nutritional status, evaluated by nutrition risk screening (NRS 2002), at the start and during the 1st year of investigators' intervention.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Min Liu, M.D.
Phone
86-731-88618717
Email
liumin330@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Meng Wang, M.M.
Phone
86-731-88618717
Email
znxywm@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Min Liu, M.D.
Organizational Affiliation
specify unaffiliated
Official's Role
Study Director
Facility Information:
Facility Name
the Third Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min Liu, M.D.
Phone
86-731-88618717
Email
liumin330@hotmail.com
First Name & Middle Initial & Last Name & Degree
Meng Wang, M.M.
Phone
86-731-88618717
Email
znxywm@163.com
First Name & Middle Initial & Last Name & Degree
Min Liu, M.D.
First Name & Middle Initial & Last Name & Degree
Hao Zhang, M.D.

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
During the experiment, investigators will share the development in the website.

Learn more about this trial

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

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