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

NCT00591097 | Completed

• 1 other identifier: M-2005-1376
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 2

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.

Conditions

Healthy

Keywords

urine; pediatric; Normal urine from healthy pediatric population

Outcome Measures

Primary Outcomes (1)

• Define normal reference ranges for urinary metabolites in the pediatric population

  Assessed one time with normal urine

Secondary Outcomes (1)

• Determine supersaturation indices in normal urine of the pediatric population

  Assessed one time in normal urine

Study Arms (1)

pediatric

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Medical College of Wisconsin: collaborator

Study Sites (2)

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

Charles Durkee, MD

Milwaukee, Wisconsin, 53226, United States

Location

Study Officials

• Bruce L. Slaughenhoupt, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2007
• First Posted: January 11, 2008
• Study Start: October 1, 2006
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: December 18, 2013

Record last verified: 2013-12

Locations

US (2)