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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK137784 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Texas, Southwestern Medical Center at Dallas | OTHER |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The goal of this clinical trial study is to test if patients with idiopathic calcium oxalate kidney stones have an increased production of oxalate by the body, which would lead to increased urinary excretion of oxalate.
The study will recruit adult patients with a history of calcium oxalate kidney stones and healthy volunteers without kidney stones.
Participants will
ingest fixed diets containing low amounts of oxalate for 5 days ingest a soluble form of glycolate and vitamin C collect urine, blood, stool during the dietary and oral dosing portions of the study and also collect breath sample during the oral glycolate test
In this study the investigators propose to measure the production of oxalate by the body (endogenous oxalate synthesis), after equilibration on a low oxalate diet (<60 mg oxalate/day, 600-800 mg calcium/day) and estimate the importance of vitamin C and glycolate metabolism to oxalate production in both Calcium Oxalate Kidney Stone patients and matched controls by oral dosings of those two substances.
Phase 1. Screening and low-oxalate diet 24-hr urinary excretions. Between the University of Alabama at Birmingham (UAB) and the University of Texas Southwestern Medical Center (UTSW), the study will enroll 40 subjects with idiopathic Calcium Oxalate Kidney Stone (20 Males/20 Females) and 40 non-kidney stone forming controls (20 Males/20 Females). Participants in the two groups will be matched for age (within 10 yrs) and gender. Screening will include blood complete metabolic profile and two 24-hour urine specimens collected at home on self-choice diets and anthropometric measurements.
Participants will then ingest the controlled low-oxalate (<60 mg/day) diet for 5 consecutive days and collect two 24-hour urines after 2 days of dietary equilibration.
Phase 2. Oxalate production and 13C-glycolate dosing tests. On Day 5, participants will arrive after an overnight fast in the research unit to undergo the oral 13C-glycolate dosing test. After a 1-hour baseline urine collection, they will ingest an oral load containing 0.5 mg/kg body weight of 13C-glycolate, dissolved in bottled water. For the next 7 hours, blood and urine will be collected hourly, and breath as more time points. They will remain on the fixed diet for 24 hours with a meal 7 hours post-load, and dinner at home 12 hours post-load. They will collect the remainder of their 24-hour urine at home.
Phase 3. Oxalate production and 13C-ascorbic acid dosing tests. After 1 day of equilibration on the same low-oxalate diet, participants will arrive after an overnight fast in the research unit to provid eone blood and one urine sample and then ingest an oral dose of 13C-ascorbic acid (0.75 mg/kg), return home and continue to ingest the low-oxalate diet. The next morning, participants will arrive after an overnight fast in the research unit. For the next 7 hours, blood and urine will be collected hourly. They will remain on the fixed diet for 24 hours with a meal at the end of the visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Idiopathic Calcium Oxalate Kidney Stone Patients | Experimental | Low oxalate fixed diets. oral glycolate and ascorbic acid administration |
|
| Healthy non-kidney stone forming individuals | Active Comparator | Low oxalate fixed diets. oral glycolate and ascorbic acid administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-oxalate diet and glycolate dosing | Dietary Supplement | Low-oxalate diet 4 days of fixed eucaloric diet with low oxalate (<60 mg/day), normal calcium content (600-1000 mg/day) |
| Measure | Description | Time Frame |
|---|---|---|
| Estimated endogenous oxalate synthesis (oxalate mg/day) | Basal rate of endogenous oxalate synthesis estimated by repeat fasted hourly urine collections (mg/day) | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| 24-hour urinary oxalate excretion on low oxalate diet | mean 24-hour urinary oxalate excretion on the low oxalate diet (mg/day) | 2 days |
| contribution of ascorbic acid breakdown to urinary oxalate excretion |
| Measure | Description | Time Frame |
|---|---|---|
| Contribution of glycolate metabolism to urinary oxalate | Proportion of 13C-glycolate orally dosed that is metabolized to urinary 13C-oxalate in the fasted stated (%) | 1 day |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sonia Fargue, PhD | Contact | 205-975-6932 | sfargue@uabmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Sonia Fargue, PhD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| United States, Alabama University of Alabama at Birmingham | Recruiting | Birmingham | Alabama | 35294 | United States |
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| Oral glycolate dosing | Dietary Supplement | Oral 13C-glycolate dosing (0.5 mg/kg) |
|
| Oral 13C- ascorbic acid dosing | Dietary Supplement | Oral 13C- ascorbic acid dosing (0.75 mg/kg) |
|
contribution of ascorbic acid breakdown to oxalate synthesis (%)
| 2 days |
| University of Texas South Western Medical Center | Not yet recruiting | Dallas | Texas | 75390 | United States |
|
| ID | Term |
|---|---|
| D007669 | Kidney Calculi |
| D052878 | Urolithiasis |
| C563477 | Nephrolithiasis, Calcium Oxalate |
| D053040 | Nephrolithiasis |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D014545 | Urinary Calculi |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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