Enteric Oxalate Absorption Study in Unclassified Hyperoxaluria
This trial is active, not recruiting.
|Conditions||enteric hyperoxaluria, hyperoxaluria|
|Treatment||c-13 labeled oxalate|
|Collaborator||National Institutes of Health (NIH)|
|Start date||December 1998|
|End date||October 2015|
|Trial size||125 participants|
|Trial identifier||NCT00588120, 1026-98, 1U54DK083908-01, RFA-OD-08-001|
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.
|Intervention model||single group assignment|
Urine oxalate measured following absorption of oral oxalate dose
time frame: 2 years
Male or female participants at least 4 years old.
Inclusion Criteria: - Age equal to or greater than 4 years (patient must be able to void on request). - Have good health. Exclusion Criteria: - Any prior history of renal disease, or hypertension - ALL subjects (controls and affected patients) will be asked to discontinue any diuretics, calcium supplements, H2 blockers, proton pump inhibitors or gastrointestinal motility agents for approximately one week prior to initiation of the study. - Subjects with GFR < 50 cc/min will be excluded.
|Official title||Investigations Into the Genotype and Phenotype of Unclassified Hyperoxaluria: Enteric Oxalate Absorption Study|
|Principal investigator||Dawn Milliner|
|Description||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.|
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