NCT05229952

Assessment of Endogenous Oxalate Synthesis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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 oxalate, timed with blood and urine collections, to determine the daily rate of endogenous oxalate synthesis in non-stone forming volunteers and in subjects with calcium oxalate kidney stones. A DXA scan will be used to assess body composition.

Conditions

• Healthy
• Kidney Stone
• Obesity

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Low-oxalate controlled diet	Participants will consume a diet that is controlled in its contents of protein, carbohydrates, fat, calcium, oxalate, vitamin C and sodium for 5 days. Participants will be asked not to take any dietary supplements, exercise strenuously, or consume food or drink that is not provided to them.
OTHER	Primed, continuous intravenous infusion of 13C2-oxalate	Participants will receive a continuous intravenous administration of carbon-13 oxalate, a naturally occurring form of oxalate, over the course of several hours until steady-state is achieved, using an IV catheter, while remaining fasting.

Timeline

• Start date: 2022-02-10
• Primary completion: 2024-09-09
• Completion: 2024-09-09
• First posted: 2022-02-08
• Last updated: 2025-05-13
• Results posted: 2024-12-11

Locations

1 site across 1 country: United States