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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:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00588120
First received: December 26, 2007
Last updated: June 19, 2012
Last verified: June 2012
History of Changes
  Purpose

The purpose of this study is to learn more about a condition called 'unclassified hyperoxaluria'. People with this condition have large amounts of oxalate (a salt) 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 examine how oxalate in the diet affects this condition. We will compare the results of affected patients to healthy volunteers.


Condition Intervention
Enteric Hyperoxaluria
Unclassified Hyperoxaluria
 Drug: 13C-oxalate
Drug: C-13 Oxalate

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Investigations Into the Genotype and Phenotype of Unclassified Hyperoxaluria: Enteric Oxalate Absorption Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • To gain knowledge on how oxalate in the diet affects Enteric Hyperoxaluria [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 125
Study Start Date: December 1998
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: C-13 Oxalate dose
Hyperoxaluric patients
 Drug: 13C-oxalate
13C Oxalate (Jell-O) Take Jell-O by mouth for one day. 13C Oxalate (Capsule) Take one capsule by mouth for one day.
Other Name: C-13 Oxalate
Drug: C-13 Oxalate
Participants oxalate intake and output will be monitored and assessed over a 24 hour period. Participants will ingest a prescribed C-13 oxalate dose and urine oxalate will be monitored for the 24 hour study period.

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.

  Eligibility

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

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

Locations
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)
Investigators
Principal Investigator: Dawn Milliner Mayo Clinic
  More Information

Additional Information:
Mayo Clinic Clinical Trials  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Dr. Dawn Milliner, 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: June 19, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Hyperoxaluria
Unknown Hyperoxaluria
Enteric Hyperoxaluria
Oxaluric
 High Oxalate
Oxalate
C13
Oxalate Diet

Additional relevant MeSH terms:
Hyperoxaluria
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on October 17, 2012