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OpenTrials
Completed

NCT Number: NCT00591097

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

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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Key information

Conditions

Healthy

Age range

3 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Wisconsin Hospital and Clinics, Madison, Wisconsin, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Define normal reference ranges for urinary metabolites in the pediatric population

    Time frame: Assessed one time with normal urine

Secondary outcomes

  1. Determine supersaturation indices in normal urine of the pediatric population

    Time frame: Assessed one time in normal urine

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • Medical College of Wisconsin

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2011
Study completion
2011
First posted
Jan 11, 2008
Registry last updated
Dec 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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