Etiological Diagnosis of Urinary Stone in Chinese Children

October 28, 2016 updated by: Hongquan Geng, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

The incidence of nephrolithiasis in children has been reported to increase by approximately 6-10% annually, and the incidence is currently 50 per 100,000 children with high recurrent rate. Investigators aimed to determine the metabolic risk factors in Chinese children through metabolic evaluation.

In order to identify diagnostic criteria of hypocitraturia and hyperoxaluria in western country wether adapt to Chinese children, investigators aim to determine normal urine levels of oxalate and citrate in children without kidney stone.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Investigators aimed to determine the metabolic risk factors in 200 Chinese children with urinary stones through metabolic evaluation.

In order to identify diagnostic criteria of hypocitraturia and hyperoxaluria in western country wether adapt to Chinese children, investigators aim to determine normal urine levels of oxalate and citrate in children without kidney stone.

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Shanghai, China
        • Department of Pediatric urology,Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 16 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children with urinary stones

Description

Inclusion Criteria:

  • Children with urinary stones

Exclusion Criteria:

  • Anatomic urinary system abnormality, vesicoureteral reflux, urinary tract infection (temperature >38°C and/or positive urine culture), solitary kidney, and renal insufficiency

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
children with urinary stones
Other: urinary stone
patients of group one have urinary stones
children without urinary stones

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Urinary oxalate;
Time Frame: urine collected in 24 hours
urine collected in 24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Urinary citrate;
Time Frame: urine collected in 24 hours
urine collected in 24 hours
Urinary calcium
Time Frame: urine collected in 24 hours
urine collected in 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Investigators

  • Study Chair: Hongquan Geng, M.D, Department of Pediatric urology,Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
  • Principal Investigator: Lei He, M.D, Department of Pediatric urology,Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

October 26, 2016

First Submitted That Met QC Criteria

October 28, 2016

First Posted (Estimate)

October 31, 2016

Study Record Updates

Last Update Posted (Estimate)

October 31, 2016

Last Update Submitted That Met QC Criteria

October 28, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XH-16-026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

no plan

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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