Scientists investigate Oxalate's role in kidney stone development
NCT ID NCT05417568
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study aims to understand how oxalate, a substance found in many foods, contributes to kidney stone formation and affects the body's immune system. Researchers will enroll 88 healthy volunteers and people with calcium oxalate kidney stones. Participants will follow a controlled diet for about three weeks and provide blood and urine samples for analysis.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 88 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2023
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Men and women between the ages of 18 and 60 years old. * Able to provide informed consent. * BMI between 20-30 kg/m2. * Non-tobacco users or not pregnant/breastfeeding/nursing. * Normal fasting blood comprehensive metabolic panel, complete blood count, C-reactive protein, and urinalysis. Must accurately collect two 24-hour urine collections within 20% of the appropriate ratio of creatinine (mg)/body weight (kg) for respective gender. * Healthy subjects: No history of CaOx KS or other medical conditions. * Patients with CaOx KS: Recent stone composition \> 50% CaOx; no uric acid, struvite, or carbonate apatite stone content. Must be first-time or recurrent CaOx stone former (last stone event ≤ 3 years). * Willing to not consume supplements (i.e. vitamins, Ca (citrate or carbonate) and other minerals, herbal supplements, nutritional aids, and probiotics) for 2 weeks before the study and during the study. * Willing to abstain from vigorous exercise during the study as this may compromise immune function. * Willing to consume diets provided only by the UAB CCTS Bionutrition Core. No food allergies or intolerance to any of the foods on the study menus. * Willing to accurately collect 24-hour urine samples, and to have blood drawn throughout the study. * If on medications for KS prevention (e.g. thiazides, citrate supplementation excluding calcium citrate), patients must be on a stable dose regimen for at least 8 weeks prior to and during screening, with no changes in dosing anticipated during the study. Patients should not take allopurinol for 2 weeks prior to screening since allopurinol has antioxidant properties. Exclusion Criteria: * Failure to meet the inclusion criteria or physician refusal. * Inability to sign and read the informed consent. * Any medical, psychiatric, or social conditions that would prohibit participants from abiding by the study requirements. * BMI ˃30 kg/m2 and \<20 kg/m2 * Tobacco users or pregnant or breastfeeding/nursing women. * Abnormal fasting blood comprehensive metabolic panel, complete blood count, C-reactive protein, and urinalysis. Inaccurate 24-hour urine collections. * Healthy subjects: Currently taking or have recently taken medications within the last 3 months (i.e. antibiotics) or dietary supplements. History of KS or any medical condition that could influence absorption or excretion of oxalate. * Active illness including COVID-19, flu, common cold, fever, diarrhea, urinary tract infections, or other infections 14 days before the study and throughout the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Alabama at Birmingham
RECRUITINGBirmingham, Alabama, 35294, United States
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