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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00591097
Recruitment Status : Completed
First Posted : January 11, 2008
Last Update Posted : December 18, 2013
Medical College of Wisconsin
Information provided by (Responsible Party):
University of Wisconsin, Madison

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.

Condition or disease

Study Type : Observational
Actual Enrollment : 300 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Determining Normal Reference Ranges for Urinary Metabolites and Supersaturation Indices in the Pediatric Population
Study Start Date : October 2006
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011


Primary Outcome Measures :
  1. Define normal reference ranges for urinary metabolites in the pediatric population [ Time Frame: Assessed one time with normal urine ]

Secondary Outcome Measures :
  1. Determine supersaturation indices in normal urine of the pediatric population [ Time Frame: Assessed one time in normal urine ]

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00591097

United States, Wisconsin
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Charles Durkee, MD
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
University of Wisconsin, Madison
Medical College of Wisconsin
Principal Investigator: Bruce L. Slaughenhoupt, MD University of Wisconsin, Madison

Responsible Party: University of Wisconsin, Madison Identifier: NCT00591097     History of Changes
Other Study ID Numbers: M-2005-1376
First Posted: January 11, 2008    Key Record Dates
Last Update Posted: December 18, 2013
Last Verified: December 2013

Keywords provided by University of Wisconsin, Madison:
Normal urine from healthy pediatric population