Enteric Oxalate Absorption Study in Unclassified Hyperoxaluria

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
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:
NCT00588120
First received: December 26, 2007
Last updated: November 30, 2015
Last verified: November 2015

December 26, 2007
November 30, 2015
December 1998
October 2016   (final data collection date for primary outcome measure)
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.
To gain knowledge on how oxalate in the diet affects Enteric Hyperoxaluria [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00588120 on ClinicalTrials.gov Archive Site
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Enteric Oxalate Absorption Study in Unclassified Hyperoxaluria
Investigations Into the Genotype and Phenotype of Unclassified Hyperoxaluria: Enteric Oxalate Absorption Study
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.
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.
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Enteric Hyperoxaluria
  • Hyperoxaluria
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
Experimental: C-13 labeled oxalate
Hyperoxaluric patients
Intervention: Drug: C-13 labeled oxalate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
125
October 2016
October 2016   (final data collection date for primary outcome measure)

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.
Both
4 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00588120
1026-98, RFA-OD-08-001, 1U54DK083908-01
Yes
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Dawn S. Milliner, M.D., Mayo Clinic
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
Mayo Clinic
November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP