Gut Oxalate Absorption in Calcium Oxalate Stone Disease
NCT ID: NCT06331546
Last Updated: 2025-05-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
80 participants
INTERVENTIONAL
2024-04-17
2031-12-31
Brief Summary
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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 and moderately high amounts of oxalate for 5 days at a time
* ingest a soluble form of oxalate and sugar preparations to test gut permeability
* collect urine, blood, stool and breath sample during the fixed diets and the soluble oxalate test
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Detailed Description
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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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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Idiopathic Calcium Oxalate Kidney Stone Patients
Low and High oxalate fixed diets. Soluble oxalate absorption test.
Low-oxalate diet
4 days of fixed eucaloric diet with low oxalate (\<60 mg/day), normal calcium content (600-1000 mg/day)
High-oxalate diet
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
Oral ingestion of 13C2-oxalate and sucralose.
Healthy non-kidney stone forming individuals
Low and High oxalate fixed diets. Soluble oxalate absorption test.
Low-oxalate diet
4 days of fixed eucaloric diet with low oxalate (\<60 mg/day), normal calcium content (600-1000 mg/day)
High-oxalate diet
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
Oral ingestion of 13C2-oxalate and sucralose.
Interventions
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Low-oxalate diet
4 days of fixed eucaloric diet with low oxalate (\<60 mg/day), normal calcium content (600-1000 mg/day)
High-oxalate diet
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
Oral ingestion of 13C2-oxalate and sucralose.
Eligibility Criteria
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Inclusion Criteria
* Body Mass Index \> 18.5 kg/m2
* Normal fasting serum electrolytes on comprehensive metabolic profile
* Willing to ingest fixed diets
* Willing to stop supplements (vitamins including vitamin C, calcium (citrate or carbonate) and other minerals, herbal supplements, nutritional aids, probiotics) for 2 weeks before start and during study.
* For stone formers: first time or recurrent Calcium Oxalate stone former. Composition of most recent stone ≥ 50% calcium oxalate if available, uric acid component \<20%
Exclusion Criteria
* Primary hyperoxaluria, Enteric (secondary) hyperoxaluria
* Liver, bowel, endocrine or renal diseases (other than idiopathic Calcium Oxalate kidney stones) or any other condition that may influence the absorption, transport or urinary excretion of ions, which will compromise the interpretation of results, including: Cystic fibrosis, Celiac disease, Cystinuria, Uric acid stone former, Nephrotic syndrome, Sarcoidosis, Renal tubular acidosis, Primary hyperparathyroidism, Neurogenic bladder, Urinary diversion, Chronic diarrhea, Bariatric surgery, Inflammatory bowel disease
* Pregnancy or breast-feeding
* Incompatible dietary requirements with the study, food allergies or intolerance to any of the foods in study menus
* Active malignancy or treatment for malignancy within 12 months prior to screening
* Utilization of immunosuppressive medication
* Uncontrolled hypertension or diabetes
* Diabetes type 1
* Chronic NSAID use
18 Years
70 Years
ALL
Yes
Sponsors
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University of Texas Southwestern Medical Center
OTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
University of Alabama at Birmingham
OTHER
Responsible Party
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Sonia Fargue
Assistant Professor
Principal Investigators
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Sonia Fargue, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
UTSW
Dallas, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IRB300004693-GIA
Identifier Type: -
Identifier Source: org_study_id
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