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
  Purpose

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
Healthy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Determining Normal Reference Ranges for Urinary Metabolites and Supersaturation Indices in the Pediatric Population

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Define normal reference ranges for urinary metabolites in the pediatric population [ Time Frame: Assessed one time with normal urine ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determine supersaturation indices in normal urine of the pediatric population [ Time Frame: Assessed one time in normal urine ] [ Designated as safety issue: No ]

Enrollment: 300
Study Start Date: October 2006
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   3 Years to 18 Years
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00591097

Locations
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
Investigators
Principal Investigator: Bruce L. Slaughenhoupt, MD University of Wisconsin, Madison
  More Information

No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00591097     History of Changes
Other Study ID Numbers: M-2005-1376
Study First Received: December 27, 2007
Last Updated: December 17, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 28, 2014