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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00895765
Recruitment Status : Unknown
Verified May 2009 by Zhejiang University.
Recruitment status was:  Enrolling by invitation
First Posted : May 8, 2009
Last Update Posted : May 8, 2009
Information provided by:
Zhejiang University

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

Condition or disease

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
Estimated Enrollment : 250 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Part 1 The Outcome of Children With Melamine-Related-Calculus
Study Start Date : September 2008
Estimated Primary Completion Date : September 2009
Estimated Study Completion Date : October 2009

Primary Outcome Measures :
  1. The calculus measured by sonography [ Time Frame: at 1, 3, 6 and 12 months ]

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

Biospecimen Retention:   Samples Without DNA
Blood and Urine

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
young children with melamine-related-calculus

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00895765

China, Zhejiang
The Children's Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310003
Sponsors and Collaborators
Zhejiang University
Principal Investigator: Zou Chao Chun, Master Departemnt of Endocrinology and Children Health care

Responsible Party: Chao Chun Zou, The Children's Hospital of Zhejiang University Identifier: NCT00895765     History of Changes
Other Study ID Numbers: zoucc1
First Posted: May 8, 2009    Key Record Dates
Last Update Posted: May 8, 2009
Last Verified: May 2009

Keywords provided by Zhejiang University:

Additional relevant MeSH terms:
Pathological Conditions, Anatomical