NCT00895765

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2008

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 8, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

May 8, 2009

Status Verified

May 1, 2009

Enrollment Period

1 year

First QC Date

May 7, 2009

Last Update Submit

May 7, 2009

Conditions

Calculus

Keywords

MelamineCalculusKidneyChild

Outcome Measures

Primary Outcomes (1)

  • The calculus measured by sonography

    at 1, 3, 6 and 12 months

Secondary Outcomes (1)

  • Renal function (e.g., creatinine, microglobulin)

    at 1, 3, 6 and 12 months

Eligibility Criteria

AgeUp to 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

young children with melamine-related-calculus

You may qualify if:

  • 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

You may not qualify if:

  • children with other congenital renal abnormality
  • children with hypercalciuria
  • children have abnormality of parathyroid gland

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Children's Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood and Urine

MeSH Terms

Conditions

Calculi

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Zou Chao Chun, Master

    Departemnt of Endocrinology and Children Health care

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 7, 2009

First Posted

May 8, 2009

Study Start

September 1, 2008

Primary Completion

September 1, 2009

Study Completion

October 1, 2009

Last Updated

May 8, 2009

Record last verified: 2009-05

Locations

CN(1)