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Completed

NCT Number: NCT00588120

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.

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Key information

Conditions

Enteric Hyperoxaluria Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hyperoxaluria Kidney Diseases Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

4 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

C-13 labeled oxalate

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.

Other names: oxalate

Primary outcomes

  1. Urine oxalate measured following absorption of oral oxalate dose

    Time frame: 2 years

    Subjects with hyperoxaluria will be given an oral test dose of oxalate, with measurement of urine oxalate excretion over the next 24 hours.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • National Institutes of Health (NIH)
  • Oxalosis and Hyperoxaluria Foundation (OHF)

Registry information

Official study title

Investigations Into the Genotype and Phenotype of Unclassified Hyperoxaluria: Enteric Oxalate Absorption Study

Important dates

Study start
1998
Primary completion
2020
Study completion
2020
First posted
Jan 8, 2008
Registry last updated
Mar 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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