The Follow up of Chinese Young Children With Melamine-Rel... | NCT00895765

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

NCT00895765

Sponsor

Zhejiang University

Status

Unknown status

Last Update Posted

May 8, 2009Estimated

Enrollment

250Estimated

Phase

Not provided

Conditions

Calculus

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2008

Primary Completion Date

Sep 2009Estimated

Completion Date

Oct 2009Estimated

First Submitted Date

May 7, 2009

First Submission Date that Met QC Criteria

May 7, 2009

First Posted Date

May 8, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 7, 2009

Last Update Posted Date

May 8, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

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.
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.
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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

250Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The calculus measured by sonography		at 1, 3, 6 and 12 months

Secondary Outcomes

Measure	Description	Time Frame
Renal function (e.g., creatinine, microglobulin)		at 1, 3, 6 and 12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

5 Years

Standard Ages

Child

Study Population

young children with melamine-related-calculus

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Zou Chao Chun, Master	Departemnt of Endocrinology and Children Health care	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Children's Hospital of Zhejiang University School of Medicine		Hangzhou	Zhejiang	310003	China

Condition Browse Module

MeSH Terms

ID	Term
D002137	Calculi

Ancestor Terms

ID	Term
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Type	Description	Link
2008ZX007
20082X010