NCT03377413

Brief Summary

The energy and nutrition states are closely associated with CKD patients complications and outcomes.To reach the energy balance target, we need the accurate resting energy expenditure level of patients. Traditional equations are not applicable to CKD patients,so we aim to develop and validate a equation for estimating resting energy expenditure in CKD patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 14, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

December 14, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 19, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2020

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

October 14, 2020

Status Verified

October 1, 2020

Enrollment Period

2.1 years

First QC Date

December 14, 2017

Last Update Submit

October 13, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • Novel equation development

    Developed equation for estimating REE in CKD 3-5 stages patients

    September 1, 2017 to June 1, 2018

  • Novel equation validation

    Validate the noval equation with REE obtained by indirect calorimetry (IC).

    June 1, 2018 to March 1, 2019

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

chronic kidney disease 3-5 stages

You may qualify if:

  • CKD 3-5 stages
  • Age:18-80 years old

You may not qualify if:

  • Dialysis and kidney transplantation;
  • Acute complications to hospitalization
  • month prior to the study;
  • Acute or chronic infections, cancer and other wasting diseases in the past year;
  • Thyroid dysfunction;
  • Acute onset of podagra; Musculoskeletal diseases;
  • Respiratory diseases (asthma, pleural effusion, pneumothorax, COPD);
  • History of hormonal drugs use;
  • During pregnancy or lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renal Division and Institute of Nephrology, Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Related Publications (1)

  • Xu X, Yang Z, Ma T, Li Z, Chen Y, Zheng Y, Dong J. Novel equation for estimating resting energy expenditure in patients with chronic kidney disease. Am J Clin Nutr. 2021 Jun 1;113(6):1647-1656. doi: 10.1093/ajcn/nqaa431.

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

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

Study Officials

  • Jie Dong

    Renal Division and Institute of Nephrology, Peking University First Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor in Renal Division, Department of Medicine

Study Record Dates

First Submitted

December 14, 2017

First Posted

December 19, 2017

Study Start

December 14, 2017

Primary Completion

January 31, 2020

Study Completion

February 1, 2020

Last Updated

October 14, 2020

Record last verified: 2020-10

Locations