NCT02886975

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

August 7, 2016

Completed
25 days until next milestone

First Posted

Study publicly available on registry

September 1, 2016

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

April 19, 2019

Status Verified

April 1, 2019

Enrollment Period

3.3 years

First QC Date

August 7, 2016

Last Update Submit

April 17, 2019

Conditions

Renal Insufficiency, Chronic

Keywords

Renal Insufficiency, ChronicDiet, Protein-Restricted

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Compliance to diet

    1 year

  • Nutritional status

    1 year

Study Arms (1)

low protein diet plus α-keto acid

EXPERIMENTAL

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

Interventions

low protein diet plus α-keto acidBEHAVIORAL

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

Also known as: low protein diet
low protein diet plus α-keto acid

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the Third Xiangya Hospital of Central South University

Changsha, Hu'nan, 410013, China

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Diet, Protein-Restricted

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Min Liu, M.D.

    specify unaffiliated

    STUDY DIRECTOR

Central Study Contacts

Min Liu, M.D.

CONTACT

86-731-88618717liumin330@hotmail.com

Meng Wang, M.M.

CONTACT

86-731-88618717znxywm@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2016

First Posted

September 1, 2016

Study Start

August 1, 2016

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

April 19, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will share

During the experiment, investigators will share the development in the website.

Locations

CN(1)