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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00591097

Enrollment

300

Registered

2008-01-11

Start date

2006-10-31

Completion date

2011-10-31

Last updated

2013-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

urine, pediatric, Normal urine from healthy pediatric population

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

3 Years to 18 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results