Investigating how the gut absorbs oxalate in kidney stone patients
Gastrointestinal Oxalate Absorption in Calcium Oxalate Stone Disease
This study is trying to see if people with kidney stones absorb more oxalate from their diet than healthy individuals, which might lead to more oxalate in their urine.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Locations | 2 sites (Birmingham, Alabama and 1 other locations) |
| Trial ID | NCT06331546 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to determine if patients with idiopathic calcium oxalate kidney stones absorb more dietary oxalate, leading to increased urinary oxalate excretion. The study will recruit both kidney stone patients and healthy volunteers, who will follow controlled low and high oxalate diets for five days. Participants will undergo a 13C2-oxalate absorption test to measure gut permeability, with urine, blood, stool, and breath samples collected throughout the study. The goal is to better understand the relationship between dietary oxalate absorption and kidney stone formation.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-70 with a history of calcium oxalate kidney stones.
Not a fit: Patients with chronic kidney disease, primary hyperoxaluria, or other significant renal or metabolic disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved dietary recommendations for preventing calcium oxalate kidney stones.
How similar studies have performed: While there have been studies on dietary oxalate and kidney stones, this specific approach to measuring gut absorption is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Birmingham, Alabama and 1 other locations
- University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
- Utsw — Dallas, Texas, United States (Active_not_recruiting)
Study contacts
- Principal investigator: Sonia Fargue, PhD — University of Alabama at Birmingham
- Study coordinator: Sonia Fargue, PhD
- Email: sfargue@uabmc.edu
- Phone: 2059756932
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.