Normal Reference Ranges for Urinary Metabolites and Supersaturation Indices in Pediatric Populations

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-10-31

Study Completion Date

2011-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Keywords

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urine pediatric Normal urine from healthy pediatric population

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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pediatric

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Healthy male and female children between the ages of 3 and 18, inclusive, of all races who are toilet trained and who can submit a 24-hour urine sample

Exclusion Criteria

* Active urinary tract infection
* Known urologic anatomic abnormality
* Personal or first-degree relative family history of urolithiasis or metabolic abnormality known to lead to urinary stone development
* Renal insufficiency
* Inability to collect a 24-hour urine specimen
* Intake of medications known to alter the risk of stone development such as steroids or diuretics or vitamins or calcium supplementation exceeding recommended daily allowances
* Adherence to restrictive diet for medical reasons
* Inflammatory or absorptive bowel disease

Minimum Eligible Age

3 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bruce L. Slaughenhoupt, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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University of Wisconsin Hospital and Clinics

Madison, Wisconsin, United States

Site Status

Charles Durkee, MD

Milwaukee, Wisconsin, United States