The Follow up of Chinese Young Children With Melamine-Related-Calculus

Calculus Clinical Trial

Official title:

Part 1 The Outcome of Children With Melamine-Related-Calculus

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00895765
• Other study ID #: zoucc1
• Secondary ID: 2008ZX00720082X0
• Status: Enrolling by invitation
• Phase: N/A
• First received: May 7, 2009
• Last updated: May 7, 2009
• Start date: September 2008
• Est. completion date: October 2009

Study information

• Verified date: May 2009
• Source: Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to investigate the lesions, clinical features and outcome in young children with melamine-related-calculus.

Description:

1. To investigate the outcome of melamine-related-calculus.

• The change of calculus.

• The change of obstruction features,including hydronephrosis and ureterectasia.

• The change of the urinalysis.

2. To investigate the change of renal function in children with melamine-related-calculus during the follow up.

• Creatinine, urea and uric acid.

• α and β2 microglobulin.

3. To analysis the factors might be associated with the outcome.

• The characteristics of patients: age, gender, and so on.

• The characteristics of calculus: location, size, and so on.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 250
• Est. completion date: October 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 5 Years

Eligibility

Inclusion Criteria:

• children with melamine-related-calculus: with a history of melamine contaminated products

• the parents leave the detailed information for contact and willing to be recalled

Exclusion Criteria:

• children with other congenital renal abnormality

• children with hypercalciuria

• children have abnormality of parathyroid gland

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Calculi
• Calculus

Locations

Country	Name	City	State
China	The Children's Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The calculus measured by sonography		at 1, 3, 6 and 12 months	Yes
Secondary	Renal function (e.g., creatinine, microglobulin)		at 1, 3, 6 and 12 months	Yes