Investigating oxalate production in patients with calcium oxalate kidney stones

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to determine if individuals with idiopathic calcium oxalate kidney stones produce more oxalate in their bodies compared to healthy individuals. Participants will follow a low-oxalate diet for five days and undergo tests involving the ingestion of glycolate and vitamin C to measure oxalate production. The study will recruit 80 subjects, including 40 kidney stone formers and 40 healthy controls, matched by age and gender. Urine, blood, and stool samples will be collected to analyze the effects of diet and oral dosing on oxalate synthesis.

Why it matters

Who can join: the full rules

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

Where it's running

• United States, Alabama University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting
• University of Texas South Western Medical Center
  Dallas, Texas, United States Not yet recruiting

Study contacts

• Principal investigator: Sonia Fargue, PhD — University of Alabama at Birmingham
• Study coordinator: Sonia Fargue, PhD
• Email: sfargue@uabmc.edu
• Phone: 205-975-6932

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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  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.

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• Using gut bacteria to reduce urinary oxalate in kidney stone patients

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• Gentamicin Irrigation and Suction Ureteral Access in Kidney Stone Surgery

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• Suction to collapse the kidney's collecting system after RIRS (retrograde intrarenal surgery)

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.