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

Determining Normal Reference Ranges for Urinary Metabolites and Supersaturation Indices in the Pediatric Population

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.

Study Overview

• Status: Completed
• Conditions: Healthy

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin Hospital and Clinics
    • Milwaukee, Wisconsin, United States, 53226
      • Charles Durkee, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
pediatric

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Define normal reference ranges for urinary metabolites in the pediatric population	Assessed one time with normal urine

Secondary Outcome Measures

Outcome Measure	Time Frame
Determine supersaturation indices in normal urine of the pediatric population	Assessed one time in normal urine

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: Medical College of Wisconsin
• Investigators: Principal Investigator: Bruce L. Slaughenhoupt, MD, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start: October 1, 2006
• Primary Completion (ACTUAL): October 1, 2011
• Study Completion (ACTUAL): October 1, 2011

Study Registration Dates

• First Submitted: December 27, 2007
• First Submitted That Met QC Criteria: January 10, 2008
• First Posted (ESTIMATE): January 11, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): December 18, 2013
• Last Update Submitted That Met QC Criteria: December 17, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: pediatric; urine; Normal urine from healthy pediatric population
• Other Study ID Numbers: M-2005-1376