Assessment of Endogenous Oxalate Synthesis

Healthy Clinical Trial

Official title:

Assessment of Endogenous Oxalate Synthesis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05229952
• Other study ID #: IRB-151020005
• Status: Recruiting
• Phase: N/A
• Start date: February 10, 2022
• Est. completion date: October 2030

Study information

• Verified date: February 2024
• Source: University of Alabama at Birmingham
• Contact: Sonia Fargue, PhD
• Phone: 205-9756932
• Email: kidneystone[@]uabmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 2030
• Est. primary completion date: October 2029
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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)

• for non-stone formers, good health as judged from a medical history, reported medications, and a complete blood metabolic profile, baseline urinary oxalate excretion < 40 mg/day

• for kidney stone formers: first time or recurrent CaOx stone former with stone event within the prior 3 years. Composition of most recent stone (if known) > 50% calcium oxalate, without uric acid component.

Exclusion Criteria:

• 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 <18 or >75 years

• BMI <18.5 or >50 kg/m2

Related Conditions & MeSH terms

• Healthy
• Kidney Calculi
• Kidney Stone
• Nephrolithiasis
• Obesity

Intervention

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.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endogenous Oxalate Synthesis Rate	Daily oxalate synthesis rate (mg/day) determined by the 13c2-oxalate infusion method	day 5
Secondary	Urinary Oxalate excretion	24-hr urinary oxalate excretion (mg/day) after equilibration on the low-oxalate controlled diet, measured by ion chromatography coupled with mass spectrometry.	day 3-4
Secondary	Urinary creatinine excretion	24-hr urinary creatinine excretion (g/day) after equilibration on the low-oxalate controlled diet.	day 3-4