Understanding Oxalate Production in Kidney Stone Disease

This study is looking for adults aged 18-80 with a history of calcium oxalate kidney stones and healthy volunteers without kidney stones. The goal is to see if people with kidney stones produce more oxalate in their bodies, which could lead to more oxalate in their urine. You would follow a special low-oxalate diet for 5 days and receive oral doses of 13C-glycolate and 13C-ascorbic acid (a form of vitamin C). Researchers will measure how much oxalate your body makes to understand its role in kidney stone formation. The study aims to enroll 80 participants.

Study design
This interventional study will enroll 80 participants, including 40 with kidney stones and 40 healthy volunteers, matched for age and gender.
What's involved
You will follow a low-oxalate diet for 5 days, ingest glycolate and vitamin C, and provide urine, blood, stool, and breath samples.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, estimated endogenous oxalate synthesis, is measured at 1 day.

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NCT06989320

Endogenous Oxalate Synthesis in Idiopathic Calcium Oxalate Kidney Stone Disease

Recruiting
NAAges 18–80InterventionalBasic science
University of Alabama at Birmingham
~80 participants
Updated 2026-08-27 on ClinicalTrials.gov
What's tested:Low-oxalate diet and glycolate dosingOral glycolate dosingOral 13C- ascorbic acid dosing

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Estimated endogenous oxalate synthesis (oxalate mg/day)
Measured over 1 day
Kidney Stones
Kidney Calculi
Urolithiasis
Urolithiasis, Calcium Oxalate
Nephrolithiasis
Nephrolithiasis, Calcium Oxalate
Oxalate Urolithiasis
Healthy
Healthy Volunteer
2 sites across 2 states
Alabama1
Texas1
  • Sonia Fargue, PhD · PRINCIPAL_INVESTIGATOR · University of Alabama at Birmingham

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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
  • Estimated endogenous oxalate synthesis (oxalate mg/day)1 day

    Basal rate of endogenous oxalate synthesis estimated by repeat fasted hourly urine collections (mg/day)