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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-oxalate controlled diet | Dietary 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Endogenous Oxalate Synthesis Rate | Daily oxalate synthesis rate (mg/day) determined by the 13c2-oxalate infusion method | day 5 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Urinary Creatinine Excretion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sonia Fargue, PhD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37312251 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
individuals with and without history of calcium oxalate kidney stones
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Endogenous Oxalate Synthesis Rate | Daily oxalate synthesis rate (mg/day) determined by the 13c2-oxalate infusion method | Posted | Mean | Standard Deviation | mg/day | day 5 |
|
5 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Sonia Fargue | University of Alabama at Birmingham | 2059756932 | sfargue@uab.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 8, 2024 | Dec 8, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 24, 2021 | Sep 9, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D007669 | Kidney Calculi |
| D009765 | Obesity |
| D052878 | Urolithiasis |
| D053040 | Nephrolithiasis |
| D014570 | Urologic Diseases |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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|
| Primed, continuous intravenous infusion of 13C2-oxalate | Other | 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. |
|
24-hr urinary creatinine excretion (g/day) after equilibration on the low-oxalate controlled diet.
| day 3-4 |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body mass index | Mean | Standard Deviation | kg/m2 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | mg/day | day 3-4 |
|
|
|
| Secondary | Urinary Creatinine Excretion | 24-hr urinary creatinine excretion (g/day) after equilibration on the low-oxalate controlled diet. | Posted | Mean | Standard Deviation | g/day | day 3-4 |
|
|
|
| 0 |
| 23 |
| 0 |
| 23 |
| 0 |
| 23 |
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| D014545 | Urinary Calculi |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |