Enteric Oxalate Absorption Study in Unclassified Hyperoxaluria

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
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: December 19, 2013
Last verified: December 2013
  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: 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

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 2015
Estimated Primary Completion Date: October 2015 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Oxalosis and Hyperoxaluria Foundation (OHF)
Investigators
Principal Investigator: Dawn Milliner Mayo Clinic
  More Information

Additional Information:
No publications provided

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: December 19, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 21, 2014