Actively Recruiting
Endogenous Oxalate Synthesis in Idiopathic Calcium Oxalate Kidney Stone Disease
Led by University of Alabama at Birmingham · Updated on 2025-05-31
80
Participants Needed
2
Research Sites
344 weeks
Total Duration
On this page
Sponsors
U
University of Alabama at Birmingham
Lead Sponsor
U
University of Texas, Southwestern Medical Center at Dallas
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Endogenous Oxalate Synthesis in Idiopathic Calcium Oxalate Kidney Stone Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years
- Body Mass Index greater than 18.5 kg/m2
- Normal fasting serum electrolytes on comprehensive metabolic profile
- Willing to ingest fixed diets
- Willing to stop supplements including vitamins (such as vitamin C), calcium (citrate or carbonate), minerals, herbal supplements, nutritional aids, probiotics for 2 weeks before and during the study
- For stone formers: first time or recurrent calcium oxalate kidney stones with most recent stone composition at least 50% calcium oxalate and uric acid component less than 20% if available
You will not qualify if you...
- Chronic Kidney Disease stage 4 or 5
- Primary hyperoxaluria or enteric (secondary) hyperoxaluria
- Liver, bowel, endocrine, or renal diseases other than idiopathic calcium oxalate kidney stones
- Conditions affecting absorption, transport, or urinary excretion of ions, 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 breastfeeding
- Dietary requirements incompatible with the study or food allergies/intolerances to study foods
- Active malignancy or treatment for malignancy within 12 months prior to screening
- Use of immunosuppressive medication
- Uncontrolled hypertension or diabetes
- Type 1 diabetes
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
United States, Alabama University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Actively Recruiting
2
University of Texas South Western Medical Center
Dallas, Texas, United States, 75390
Not Yet Recruiting
Research Team
S
Sonia Fargue, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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