Normal Reference Ranges for Urinary Metabolites and Supersaturation Indices in Pediatric Populations
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- Define normal reference ranges for urinary metabolites in the pediatric population [ Time Frame: Assessed one time with normal urine ] [ Designated as safety issue: No ]
- Determine supersaturation indices in normal urine of the pediatric population [ Time Frame: Assessed one time in normal urine ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 450 |
| Study Start Date: | October 2006 |
| Estimated Study Completion Date: | October 2012 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| pediatric |
Eligibility| Ages Eligible for Study: | 3 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | 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.
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| United States, Wisconsin | |
| University of Wisconsin Hospital and Clinics | |
| Madison, Wisconsin, United States, 53792 | |
| Charles Durkee, MD | |
| Milwaukee, Wisconsin, United States, 53226 | |
| 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: | October 16, 2012 |
| 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 June 13, 2013