Enteric Oxalate Absorption Study

This study is currently recruiting participants.

Verified by Mayo Clinic, December 2007

Sponsors and Collaborators:	Mayo Clinic National Institutes of Health (NIH) Oxalosis and Hyperoxaluria Foundation (OHF)
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00588120

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment
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:	100
Study Start Date:	December 1998
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	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.

Eligibility

Ages Eligible for Study:	4 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts

Contact: Susan R Rogers	507-266-9391	rogers.susan@mayo.edu
Contact: Mayo Clinic Hyperoxaluria Center	800-270-4637	hyperoxaluriacenter@mayo.edu

Locations

United States, Minnesota
Mayo Clinic Rochester	Recruiting
Rochester, Minnesota, United States, 55905
Principal Investigator: Dawn Milliner, MD

Sponsors and Collaborators

Mayo Clinic

National Institutes of Health (NIH)

Oxalosis and Hyperoxaluria Foundation (OHF)

Investigators

Principal Investigator:

Dawn Milliner

Mayo Clinic

More Information

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

Responsible Party:	Mayo Clinic ( Dr. Dawn Milliner )
Study ID Numbers:	1026-98, DK73354-03
Study First Received:	December 26, 2007
Last Updated:	December 26, 2007
ClinicalTrials.gov Identifier:	NCT00588120
Health Authority:	United States: Institutional Review Board

Keywords provided by Mayo Clinic:

Hyperoxaluria
Unknown Hyperoxaluria
Enteric Hyperoxaluria
Oxaluric

High Oxalate
Oxalate
C13
Oxalate Diet

Study placed in the following topic categories:

Urologic Diseases
Hyperoxaluria
Kidney Diseases

ClinicalTrials.gov processed this record on January 16, 2009