Enteric Oxalate Absorption Study in Unclassified Hyperoxaluria

This study is ongoing, but not recruiting participants.
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Oxalosis and Hyperoxaluria Foundation (OHF)
Information provided by (Responsible Party):
Dawn S. Milliner, M.D., Mayo Clinic
ClinicalTrials.gov Identifier:
First received: December 26, 2007
Last updated: November 30, 2015
Last verified: November 2015
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.

Condition Intervention Phase
Enteric Hyperoxaluria
Drug: C-13 labeled oxalate
Phase 1

Study Type: Interventional
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

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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.

Estimated Enrollment: 125
Study Start Date: December 1998
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: C-13 labeled oxalate
Hyperoxaluric patients
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

Detailed 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.

Ages Eligible for Study:   4 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00588120

United States, Minnesota
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Oxalosis and Hyperoxaluria Foundation (OHF)
Principal Investigator: Dawn Milliner Mayo Clinic
  More Information

Additional Information:
Responsible Party: Dawn S. Milliner, M.D., M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT00588120     History of Changes
Other Study ID Numbers: 1026-98  RFA-OD-08-001  1U54DK083908-01 
Study First Received: December 26, 2007
Last Updated: November 30, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Unknown Hyperoxaluria
Enteric Hyperoxaluria
High Oxalate
Oxalate Diet

ClinicalTrials.gov processed this record on May 26, 2016