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Assessment of Endogenous Oxalate Synthesis

Assessment of Endogenous Oxalate Synthesis

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05229952
Enrollment
23
Registered
2022-02-08
Start date
2022-02-10
Completion date
2024-09-09
Last updated
2025-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy, Kidney Stone, Obesity

Keywords

Oxalate, Kidney stones, Urolithiasis, Nephrolithiasis, Urologic disease, Oxalate metabolism

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 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.

Interventions

DIETARY_SUPPLEMENTLow-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.

OTHERPrimed, 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.

Sponsors

University of Alabama at Birmingham
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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) * 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 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 lower than 18 or greater than 75 years * BMI lower than18.5 or greater than 50 kg/m2

Design outcomes

Primary

MeasureTime frameDescription
Endogenous Oxalate Synthesis Rateday 5Daily oxalate synthesis rate (mg/day) determined by the 13c2-oxalate infusion method

Secondary

MeasureTime frameDescription
Urinary Oxalate Excretionday 3-424-hr urinary oxalate excretion (mg/day) after equilibration on the low-oxalate controlled diet, measured by ion chromatography coupled with mass spectrometry.
Urinary Creatinine Excretionday 3-424-hr urinary creatinine excretion (g/day) after equilibration on the low-oxalate controlled diet.

Countries

United States

Participant flow

Participants by arm

ArmCount
Constant Infusion of 13C2-oxalate
Subjects who have passed screening, will consume a low-oxalate, normal calcium controlled diet for 5 days total. On Days 3 and 4, subjects will collect two 24-hour urines. On Day 5, they will receive a carbon 13 oxalate infusion which will occur at a constant rate for 6 hours, in the fasted state, following a priming dose. Hourly urine and twice hourly blood samples will be collected during the 6 hours. Meals will be resumed at the end of the infusion and timed urine collections will take place at home until the next day. A DXA scan will be performed to assess body composition at another date. 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. 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.
23
Total23

Baseline characteristics

CharacteristicConstant Infusion of 13C2-oxalate
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
23 Participants
Age, Continuous41 years
STANDARD_DEVIATION 11
Body mass index31 kg/m2
STANDARD_DEVIATION 6
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
21 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
1 Participants
Race (NIH/OMB)
Black or African American
10 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
12 Participants
Region of Enrollment
United States
23 participants
Sex: Female, Male
Female
14 Participants
Sex: Female, Male
Male
9 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 23
other
Total, other adverse events
0 / 23
serious
Total, serious adverse events
0 / 23

Outcome results

Primary

Endogenous Oxalate Synthesis Rate

Daily oxalate synthesis rate (mg/day) determined by the 13c2-oxalate infusion method

Time frame: day 5

ArmMeasureValue (MEAN)Dispersion
Constant Infusion of 13C2-oxalateEndogenous Oxalate Synthesis Rate17 mg/dayStandard Deviation 4
Secondary

Urinary Creatinine Excretion

24-hr urinary creatinine excretion (g/day) after equilibration on the low-oxalate controlled diet.

Time frame: day 3-4

ArmMeasureValue (MEAN)Dispersion
Constant Infusion of 13C2-oxalateUrinary Creatinine Excretion1.6 g/dayStandard Deviation 0.5
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.

Time frame: day 3-4

ArmMeasureValue (MEAN)Dispersion
Constant Infusion of 13C2-oxalateUrinary Oxalate Excretion20 mg/dayStandard Deviation 4

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026