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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

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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
Gut Oxalate Absorption in Calcium Oxalate Stone Disease (NCT06331546) | Bored Studies