Normal Reference Ranges for Urinary Metabolites and Supersaturation Indices in Pediatric Populations
| Tracking Information | |||||
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| First Received Date ICMJE | December 27, 2007 | ||||
| Last Updated Date | October 16, 2012 | ||||
| Start Date ICMJE | October 2006 | ||||
| Primary Completion Date | October 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Define normal reference ranges for urinary metabolites in the pediatric population [ Time Frame: Assessed one time with normal urine ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00591097 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Determine supersaturation indices in normal urine of the pediatric population [ Time Frame: Assessed one time in normal urine ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Normal Reference Ranges for Urinary Metabolites and Supersaturation Indices in Pediatric Populations | ||||
| Official Title ICMJE | Determining Normal Reference Ranges for Urinary Metabolites and Supersaturation Indices in the Pediatric Population | ||||
| Brief Summary | The reported normal values used in diagnosing and treating pediatric kidney stone formers are based on adult values or historic data from small studies. Urinary supersaturation indices which are now described in the adult stone literature as more sensitive predictors of stone composition, and precise predictors of response to therapy, are not established in children. The goals of this prospective study are to redefine normal values for pediatric urinary metabolites and supersaturation indices based on samples from a large number of healthy children and to identify if a difference in urinary supersaturations in children is protective. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | All normal, healthy volunteer children between the ages of 3 and 18, inclusive, with no personal or first relative family history of urolithiasis. Both boys and girls will be enrolled with an effort to enroll an equal number of children of all ages after toilet training. |
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| Condition ICMJE | Healthy | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | pediatric | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 450 | ||||
| Estimated Completion Date | October 2012 | ||||
| Primary Completion Date | October 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 3 Years to 18 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00591097 | ||||
| Other Study ID Numbers ICMJE | M-2005-1376 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | University of Wisconsin, Madison | ||||
| Study Sponsor ICMJE | University of Wisconsin, Madison | ||||
| Collaborators ICMJE | Medical College of Wisconsin | ||||
| Investigators ICMJE |
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| Information Provided By | University of Wisconsin, Madison | ||||
| Verification Date | October 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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