ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 532 for:    Recruiting, Not yet recruiting, Available Studies | "Renal Insufficiency, Chronic"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02886975
Recruitment Status : Recruiting
First Posted : September 1, 2016
Last Update Posted : October 25, 2017
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Renal Insufficiency, Chronic Behavioral: low protein diet plus α-keto acid Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Low Protein Diet Supplemented Keto-/Amino Acid in Preventing the Progression of Chronic Kidney Disease(CKD)
Study Start Date : August 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
Behavioral: 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
Other Name: low protein diet




Primary Outcome Measures :
  1. changes in glomerular filtration rate [ Time Frame: 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 :
  1. Compliance to diet [ Time Frame: 1 year ]
    Compliance to diet, defined by the participants' persistence in low protein diet, by outpatient follow-up and telephone follow-up.

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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02886975


Contacts
Contact: Min Liu, M.D. 86-731-88618717 liumin330@hotmail.com
Contact: Meng Wang, M.M. 86-731-88618717 znxywm@163.com

Locations
China, Hunan
the Third Xiangya Hospital of Central South University Recruiting
Changsha, Hunan, China, 410013
Contact: Min Liu, M.D.    86-731-88618717    liumin330@hotmail.com   
Contact: Meng Wang, M.M.    86-731-88618717    znxywm@163.com   
Principal Investigator: Min Liu, M.D.         
Principal Investigator: Hao Zhang, M.D.         
Sponsors and Collaborators
The Third Xiangya Hospital of Central South University
Investigators
Study Director: Min Liu, M.D. specify unaffiliated

Responsible Party: The Third Xiangya Hospital of Central South University
ClinicalTrials.gov Identifier: NCT02886975     History of Changes
Other Study ID Numbers: YYK-2016001
First Posted: September 1, 2016    Key Record Dates
Last Update Posted: October 25, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: During the experiment, investigators will share the development in the website.

Keywords provided by The Third Xiangya Hospital of Central South University:
Renal Insufficiency, Chronic
Diet, Protein-Restricted

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Urologic Diseases