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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014