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

This study has been completed.
Sponsor:
Collaborator:
Medical College of Wisconsin
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00591097
First received: December 27, 2007
Last updated: December 17, 2013
Last verified: December 2013

December 27, 2007
December 17, 2013
October 2006
October 2011   (final data collection date for primary outcome measure)
Define normal reference ranges for urinary metabolites in the pediatric population [ Time Frame: Assessed one time with normal urine ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00591097 on ClinicalTrials.gov Archive Site
Determine supersaturation indices in normal urine of the pediatric population [ Time Frame: Assessed one time in normal urine ] [ Designated as safety issue: No ]
Same as current
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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.

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Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

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.

Healthy
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pediatric
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
October 2011
October 2011   (final data collection date for primary outcome measure)

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
Both
3 Years to 18 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00591097
M-2005-1376
No
University of Wisconsin, Madison
University of Wisconsin, Madison
Medical College of Wisconsin
Principal Investigator: Bruce L. Slaughenhoupt, MD University of Wisconsin, Madison
University of Wisconsin, Madison
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP