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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 | 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 absorption of dietary oxalate, 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
In this study the investigators propose to measure the net gastrointestinal absorption of oxalate both by food-bound oxalate, using low- (<60 mg/day) and high- (250-300 mg/day) oxalate diets (600-800 mg daily calcium in both), and by the soluble 13C2-oxalate oral test in both Calcium Oxalate Kidney Stone patients and matched controls.
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-hr urine specimens collected at home on self-choice diets and anthropometric measurements.
Participants will then ingest the controlled low-oxalate (<60 mg/d) diet for 5 consecutive days and collect two 24-hr urines after 2 days of dietary equilibration.
Phase 2. 13C2-Oxalate gut absorption tests. On Day 5, participants will arrive after an overnight fast in the research unit to undergo the 13C2-oxalate absorption test. After a 1-hour baseline urine collection, they will ingest an oral load containing 100 mg 13C2-oxalate and 1 g sucralose, dissolved in bottled water. For the next 9 hrs, blood and urine will be collected hourly, and breath as more time points. They will remain on the fixed diet for 24 hrs with a breakfast 2 hours after the load, lunch 6 hrs post-load, and dinner at home 12 hrs post-load. They will collect the remainder of their 24-hr urine at home and the totality of the stool eliminated during the first 24 hrs after the load using kits provided.
Phase 3. High-oxalate diet 24-hr urinary excretions. After a minimum of 1 week wash-out period, during which participants will eat freely, participants will consume the high oxalate (250-300 mg/day) diet for the next 4 days. Two 24-hr urine specimens will be collected after 2 days of equilibration and a fasting blood draw on the morning of Day 5.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Idiopathic Calcium Oxalate Kidney Stone Patients | Experimental | Low and High oxalate fixed diets. Soluble oxalate absorption test. |
|
| Healthy non-kidney stone forming individuals | Active Comparator | Low and High oxalate fixed diets. Soluble oxalate absorption test. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-oxalate diet | Dietary Supplement | 4 days of fixed eucaloric diet with low oxalate (<60 mg/day), normal calcium content (600-1000 mg/day) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Net Gastrointestinal absorption of food-bound oxalate | difference between 24-hour urinary oxalate excretion on the high oxalate diet and the low oxalate diet, normalized to the difference in dietary oxalate composition of the two diets (%) | 4 day |
| Measure | Description | Time Frame |
|---|---|---|
| Absorption of soluble 13C2-oxalate | Proportion of 13C2-oxalate recovered in urine to the amount orally ingested (%) | 1 day |
| Estimated endogenous oxalate synthesis (oxalate mg/day) | 24-hour urinary oxalate excretion on the low oxalate diet (mg/day) |
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Inclusion Criteria:
Exclusion Criteria:
all
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sonia Fargue, PhD | Contact | 2059756932 | sfargue@uabmc.edu |
| 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 | Recruiting | Birmingham | Alabama | 35294 | United States |
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| High-oxalate diet | Dietary Supplement | 4 days of fixed eucaloric diet with moderately high oxalate (250-300 mg/day), normal calcium content (600-1000 mg/day) |
|
| soluble oxalate gut absorption test | Other | Oral ingestion of 13C2-oxalate and sucralose. |
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| 2 days |
| UTSW | Active, not recruiting | Dallas | Texas | 75390 | United States |
| ID | Term |
|---|---|
| D007669 | Kidney Calculi |
| D052878 | Urolithiasis |
| C563477 | Nephrolithiasis, Calcium Oxalate |
| D053040 | Nephrolithiasis |
| D006959 | Hyperoxaluria |
| 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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