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

May 7, 2009 updated by: Zhejiang University

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

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

Study Overview

Status

Unknown

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

250

Contacts and Locations

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

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • The Children's Hospital of Zhejiang University School of Medicine

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

No older than 5 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

young children with melamine-related-calculus

Description

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 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Zhejiang University

Investigators

  • Principal Investigator: Zou Chao Chun, Master, Departemnt of Endocrinology and Children Health care

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

September 1, 2008

Primary Completion (ANTICIPATED)

September 1, 2009

Study Completion (ANTICIPATED)

October 1, 2009

Study Registration Dates

First Submitted

May 7, 2009

First Submitted That Met QC Criteria

May 7, 2009

First Posted (ESTIMATE)

May 8, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

May 8, 2009

Last Update Submitted That Met QC Criteria

May 7, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • zoucc1
  • 2008ZX007
  • 20082X010

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.

Clinical Trials on Calculus

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Egypt

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe