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

December 26, 2007
December 19, 2013
December 1998
October 2015   (final data collection date for primary outcome measure)
To gain knowledge on how oxalate in the diet affects Enteric Hyperoxaluria [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00588120 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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 (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.

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
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Enteric Hyperoxaluria
  • Unclassified Hyperoxaluria
  • 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.
Experimental: C-13 Oxalate dose
Hyperoxaluric patients
Interventions:
  • Drug: 13C-oxalate
  • Drug: C-13 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 2015
October 2015   (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
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00588120
1026-98, RFA-OD-08-001, 1U54DK083908-01
Yes
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
December 2013

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