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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02949323
Other study ID # XH-16-026
Secondary ID
Status Not yet recruiting
Phase N/A
First received October 26, 2016
Last updated October 28, 2016
Start date November 2016
Est. completion date December 2019

Study information

Verified date October 2016
Source Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Contact Hongquan Geng, M.D
Phone +86-13801973493
Email ghongquan@hotmail.com
Is FDA regulated No
Health authority China: National Health and Family Planning Commission
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 200
Est. completion date December 2019
Est. primary completion date December 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 1 Year to 16 Years
Eligibility 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 Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
urinary stone
patients of group one have urinary stones

Locations

Country Name City State
China Department of Pediatric urology,Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Urinary oxalate; urine collected in 24 hours Yes
Secondary Urinary citrate; urine collected in 24 hours Yes
Secondary Urinary calcium urine collected in 24 hours Yes
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