Status:
COMPLETED
Assessment of Endogenous Oxalate Synthesis
Lead Sponsor:
University of Alabama at Birmingham
Conditions:
Healthy
Kidney Stone
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
This study aims to determine the daily rate of endogenous synthesis of oxalate using carbon 13 oxalate isotope tracer technique and a low-oxalate controlled diet.
Detailed Description
Urinary oxalate excretion is derived from both dietary sources and endogenous synthesis. This study will use low-oxalate controlled diet and intravenous infusion of the isotope tracer carbon 13 oxalat...
Eligibility Criteria
Inclusion
- Mentally competent adults, able to read and comprehend the consent form
- Body Mass Index (BMI) between 18.5 and 50 kg/m2
- Acceptable 24 hour urine collections (judged on screening)
- good health as judged from a medical history, reported medications, and a complete blood metabolic profile
- with or without history of calcium oxalate kidney stones
Exclusion
- History of any hepatic, bowel, or endocrine disease or other condition that may influence the absorption, transport or urine excretion of ions
- Abnormal urine chemistries or blood metabolic profiles
- Poor 24 hour urine collections completed during screening, judged by 24 hour urine creatinine excretion (indicative of not collecting all urine in the 24 hour period)
- Pregnancy, intention to become pregnant in the near future, or lactation
- Aged lower than 18 or greater than 75 years
- BMI lower than18.5 or greater than 50 kg/m2
Key Trial Info
Start Date :
February 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 9 2024
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT05229952
Start Date
February 10 2022
End Date
September 9 2024
Last Update
May 13 2025
Active Locations (1)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294