Status:
RECRUITING
Endogenous Oxalate Synthesis in Idiopathic Calcium Oxalate Kidney Stone Disease
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
University of Texas, Southwestern Medical Center at Dallas
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Kidney Stones
Kidney Calculi
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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 ex...
Detailed Description
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 calc...
Eligibility Criteria
Inclusion
- age 18-80 yrs
- 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
- Chronic Kidney Disease stage 4-5
- 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
Key Trial Info
Start Date :
May 27 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2031
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06989320
Start Date
May 27 2025
End Date
December 31 2031
Last Update
May 31 2025
Active Locations (2)
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1
United States, Alabama University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
University of Texas South Western Medical Center
Dallas, Texas, United States, 75390