Enteric Oxalate Absorption Study in Unclassified Hyperoxaluria
The purpose of this study is to learn more about a condition called 'unclassified hyperoxaluria'. People with this condition have large amounts of oxalate in their urine, which can cause kidney stones and kidney failure. We do not know what causes the high level of oxalate in the urine. In this study, we will evaluate absorption of a test dose of oxalate taken orally by measuring the amount of the test dose that is eliminated in the urine. We will compare the results of affected patients to healthy volunteers.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Investigations Into the Genotype and Phenotype of Unclassified Hyperoxaluria: Enteric Oxalate Absorption Study|
- Urine oxalate measured following absorption of oral oxalate dose [ Time Frame: 2 years ] [ Designated as safety issue: No ]Subjects with hyperoxaluria will be given an oral test dose of oxalate, with measurement of urine oxalate excretion over the next 24 hours.
|Study Start Date:||December 1998|
|Estimated Study Completion Date:||October 2015|
|Estimated Primary Completion Date:||October 2015 (Final data collection date for primary outcome measure)|
Experimental: C-13 labeled oxalate
Drug: C-13 labeled oxalate
A single prescribed dose of C-13 labeled oxalate will be given orally in capsule form or in jello. Urine will be collected for 24 hours after the dose.
Take one capsule by mouth for one day.
Other Name: oxalate
Participants' oxalate intake and output will be monitored and assessed over a 24 hour period. Participants will ingest a prescribed oxalate dose and urine oxalate will be monitored for the 24 hour study period.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00588120
|United States, Minnesota|
|Mayo Clinic Rochester|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Dawn Milliner||Mayo Clinic|