Etiological Diagnosis of Urinary Stone in Chinese Children
1 other identifier
observational
200
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2016
Typical duration for all trials
1 active site
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
October 26, 2016
CompletedFirst Posted
Study publicly available on registry
October 31, 2016
CompletedStudy Start
First participant enrolled
November 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedOctober 31, 2016
October 1, 2016
3.1 years
October 26, 2016
October 28, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Urinary oxalate;
urine collected in 24 hours
Secondary Outcomes (2)
Urinary citrate;
urine collected in 24 hours
Urinary calcium
urine collected in 24 hours
Study Arms (2)
children with urinary stones
children with urinary stones
children without urinary stones
children without urinary stones
Interventions
Eligibility Criteria
Children with urinary stones
You may qualify if:
- Children with urinary stones
You may not qualify if:
- Anatomic urinary system abnormality, vesicoureteral reflux, urinary tract infection (temperature \>38°C and/or positive urine culture), solitary kidney, and renal insufficiency
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Pediatric urology,Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Department of Pediatric Urology
Study Record Dates
First Submitted
October 26, 2016
First Posted
October 31, 2016
Study Start
November 1, 2016
Primary Completion
December 1, 2019
Study Completion
December 1, 2019
Last Updated
October 31, 2016
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will not share
no plan