Enteric Oxalate Absorption Study in Unclassified Hyperoxaluria

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-12-31

Study Completion Date

2020-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Enteric Hyperoxaluria Hyperoxaluria

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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C-13 labeled oxalate

Hyperoxaluric patients

Group Type EXPERIMENTAL

C-13 labeled oxalate

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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oxalate

Eligibility Criteria

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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.

Minimum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No