HealthyNCT05229952
Assessment of Endogenous Oxalate Synthesis
A study testing Primed, continuous intravenous infusion of 13C2-oxalate in people with Healthy and Kidney Stone, run by University of Alabama at Birmingham at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Kidney Stone, Obesity
- What is being tested?
- Primed, continuous intravenous infusion of 13C2-oxalate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2022to 9 Sep 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
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.
Read the 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
- Being tested
- Low-oxalate controlled diet, Primed, continuous intravenous infusion of 13C2-oxalate
- Keywords
- Oxalate, Kidney stones, Urolithiasis, Nephrolithiasis, Urologic disease, Oxalate metabolism
- Medical subject headings
- Kidney Calculi, Obesity, Urolithiasis, Nephrolithiasis, Urologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-oxalate controlled dietDietary supplement
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-oxalateOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Constant infusion of 13C2-oxalate | Experimental | 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. Receives: Dietary Supplement: Low-oxalate controlled diet; Other: Primed, continuous intravenous infusion of 13C2-oxalate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endogenous Oxalate Synthesis Rate
Daily oxalate synthesis rate (mg/day) determined by the 13c2-oxalate infusion method
Measured: day 5
Secondary outcomes (2)
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.
Measured: day 3-4
Urinary Creatinine Excretion
24-hr urinary creatinine excretion (g/day) after equilibration on the low-oxalate controlled diet.
Measured: day 3-4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start10 Feb 2022
- Primary completion9 Sep 2024
- Study completion9 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sonia Fargue, University of Alabama at Birmingham
- Investigators
- Sonia Fargue, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05229952
- Sponsor's protocol ID
- IRB151020005-OXI
- Status last verified
- May 2025
- First submitted
- 27 Jan 2022
- Last updated
- 13 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fargue S, Wood KD, Crivelli JJ, Assimos DG, Oster RA, Knight J. Endogenous Oxalate Synthesis and Urinary Oxalate Excretion. J Am Soc Nephrol. 2023 Sep 1;34(9):1505-1507. doi: 10.1681/ASN.0000000000000176. Epub 2023 Jun 14. No abstract available.
PubMed 37312251
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Endogenous Oxalate Synthesis
- ClinicalTrials.gov ID
- NCT05229952
- Acronym / sponsor ID
- IRB151020005-OXI
- Conditions
- Healthy, Kidney Stone, Obesity
- Keywords
- Oxalate, Kidney stones, Urolithiasis, Nephrolithiasis, Urologic disease, Oxalate metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 10 Feb 2022 (actual)
- Primary completion
- 9 Sep 2024 (actual)
- Study completion
- 9 Sep 2024 (actual)
- First posted
- 8 Feb 2022 (actual)
- Results
- Posted 11 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Constant infusion of 13C2-oxalate | Experimental | Dietary Supplement: Low-oxalate controlled diet, Other: Primed, continuous intravenous infusion of 13C2-oxalateSubjects 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-oxalate controlled dietParticipants 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. | Dietary supplement | Constant infusion of 13C2-oxalate |
| Primed, continuous intravenous infusion of 13C2-oxalateParticipants 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. | Other | Constant infusion of 13C2-oxalate |
Primary outcome
Endogenous Oxalate Synthesis Rate
Time frame: day 5
Daily oxalate synthesis rate (mg/day) determined by the 13c2-oxalate infusion method
2 secondary outcomes
Urinary Oxalate Excretion
Time frame: day 3-4
Urinary Creatinine Excretion
Time frame: day 3-4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 37312251Fargue S, Wood KD, Crivelli JJ, Assimos DG, Oster RA, Knight J. Endogenous Oxalate Synthesis and Urinary Oxalate Excretion. J Am Soc Nephrol. 2023 Sep 1;34(9):1505-1507. doi: 10.1681/ASN.0000000000000176. Epub 2023 Jun 14. No abstract available.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sonia Fargue, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Primed, continuous intravenous infusion of 13C2-oxalate in people with Healthy and Kidney Stone, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endogenous Oxalate Synthesis Rate (time frame: day 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05229952, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.