NCT06331546 Gut Oxalate Absorption in Calcium Oxalate Stone Disease
| NCT ID | NCT06331546 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Alabama at Birmingham |
| Condition | Kidney Stone |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2024-04-17 |
| Primary Completion | 2030-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2024-04-17 with a primary completion date of 2030-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 * 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
Eligibility Criteria
Inclusion Criteria: * age 18-70 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 Criteria: * 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 * Chronic NSAID use
Contact & Investigator
Sonia Fargue, PhD
PRINCIPAL INVESTIGATOR
University of Alabama at Birmingham
Frequently Asked Questions
Who can join the NCT06331546 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Kidney Stone. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06331546 currently recruiting?
Yes, NCT06331546 is actively recruiting participants. Contact the research team at sfargue@uabmc.edu for enrollment information.
Where is the NCT06331546 trial being conducted?
This trial is being conducted at Birmingham, United States, Dallas, United States.
Who is sponsoring the NCT06331546 clinical trial?
NCT06331546 is sponsored by University of Alabama at Birmingham. The principal investigator is Sonia Fargue, PhD at University of Alabama at Birmingham. The trial plans to enroll 80 participants.
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