Gut Oxalate Absorption in Calcium Oxalate Stone Disease
University of Alabama at Birmingham · with University of Texas Southwestern Medical Center, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NCT06331546
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–80 · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Not applicable
- Target enrollment
- 80
- US sites recruiting
- 2
- Study start
- April 17, 2024
- Record last updated
- October 13, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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
Being studied: Low-oxalate diet; High-oxalate diet; soluble oxalate gut absorption test
Conditions: Kidney Stone; Kidney Calculi; Urolithiasis; Urolithiasis, Calcium Oxalate; Nephrolithiasis; Nephrolithiasis, Calcium Oxalate; Oxalate Urolithiasis; Oxaluria; Healthy
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- 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 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
Recruiting US locations
University of Alabama at Birmingham
Birmingham, AL 35294
Site contact: Sonia Fargue, PhD · 205-9756932 · kidneystone@uabmc.edu
UTSW
Dallas, TX 75390
Site contact: Naim Maalouf, MD · Naim.Maalouf@UTSouthwestern.edu
Study contacts (from the official record)
- Sonia Fargue, PhD · 2059756932 · sfargue@uabmc.edu
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