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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Zhejiang University
ClinicalTrials.gov Identifier:
NCT00895765
First received: May 7, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted
  Purpose

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


Condition
Calculus

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Part 1 The Outcome of Children With Melamine-Related-Calculus

Further study details as provided by Zhejiang University:

Primary Outcome Measures:
  • The calculus measured by sonography [ Time Frame: at 1, 3, 6 and 12 months ] [ Designated as safety issue: Yes ]

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

Biospecimen Retention:   Samples Without DNA

Blood and Urine


Estimated Enrollment: 250
Study Start Date: September 2008
Estimated Study Completion Date: October 2009
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   up to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

young children with melamine-related-calculus

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00895765

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

No publications provided

Responsible Party: Chao Chun Zou, The Children's Hospital of Zhejiang University
ClinicalTrials.gov Identifier: NCT00895765     History of Changes
Other Study ID Numbers: zoucc1, 2008ZX007, 20082X010
Study First Received: May 7, 2009
Last Updated: May 7, 2009
Health Authority: China: Ethics Committee

Keywords provided by Zhejiang University:
Melamine
Calculus
Kidney
Child

Additional relevant MeSH terms:
Calculi
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 16, 2013