CalculusNCT00895765
The Follow up of Chinese Young Children With Melamine-Related-Calculus
An observational study of Calculus, run by Zhejiang University at 1 site in China.
Trial summary
The purpose of this study is to investigate the lesions, clinical features and outcome in young children with melamine-related-calculus. Read more about this study
- Who is it for?
- Ages Up to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Calculus
- How many people
- 250 participants
- Where
- 1 siteChina
- Study dates
- Sep 2008to Oct 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: young children with melamine-related-calculus
Who may be able to join
- 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
Who cannot join
- children with other congenital renal abnormality
- children with hypercalciuria
- children have abnormality of parathyroid gland
Trial locations and contacts
1 site in 1 country.
China1 site
The Children's Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
About this study
Official title: 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.
Read the detailed description
- 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.
- 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.
- 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.
- Conditions
- Calculus
- Keywords
- Melamine, Calculus, Kidney, Child
- Medical subject headings
- Calculi
What is being measured
The primary outcome is the main question the study is designed to answer.
The calculus measured by sonography
Measured: at 1, 3, 6 and 12 months
Secondary outcomes (1)
Renal function (e.g., creatinine, microglobulin)
Measured: at 1, 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2009 (estimated)
- Study startSep 2008
- Primary completionSep 2009 (estimated)
- Study completionOct 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CalculusStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Investigators
- Zou Chao Chun, Master, Principal investigator, Departemnt of Endocrinology and Children Health care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00895765
- Sponsor's protocol ID
- zoucc1
- Other IDs
- 2008ZX007, 20082X010
- Status last verified
- May 2009
- First submitted
- 7 May 2009
- Last updated
- 8 May 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Part 1 The Outcome of Children With Melamine-Related-Calculus
- ClinicalTrials.gov ID
- NCT00895765
- Acronym / sponsor ID
- zoucc1
- Conditions
- Calculus
- Keywords
- Melamine, Calculus, Kidney, Child
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Sep 2009 (estimated)
- Study completion
- Oct 2009 (estimated)
- First posted
- 8 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the lesions, clinical features and outcome in young children with melamine-related-calculus.
Detailed description
- 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.
- 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.
- 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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- young children with melamine-related-calculus
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- children with other congenital renal abnormality
- children with hypercalciuria
- children have abnormality of parathyroid gland
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The calculus measured by sonography
Time frame: at 1, 3, 6 and 12 months
1 secondary outcome
Renal function (e.g., creatinine, microglobulin)
Time frame: at 1, 3, 6 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zou Chao Chun, Master principal investigator
Departemnt of Endocrinology and Children Health care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Calculus, run by Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The calculus measured by sonography (time frame: at 1, 3, 6 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2009.