CompletedNot Applicable

Dietary Oxalate and Innate Immunity in Kidney Stone Disease

United States14 participantsStarted 2021-03-05

Plain-language summary

This study will test whether oxalate stimulates urinary crystals and impacts the immune system in healthy subjects using two controlled diets (low and high oxalate).

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Healthy subjects (men and women) between the ages of 18 and 60 years of age * No calcium oxalate kidney stones or other medical conditions * Normal comprehensive metabolic panel (CMP) * Non tobacco users * Not pregnant * BMI between 20-30 kg/m2 * Willing to abstain from vigorous exercise and vitamins/supplements during the study * Willing to consume only provided diets, accurately collect 24-hour urine samples, and have blood drawn Exclusion Criteria: * Inability to sign and read the informed consent * Any medical, psychiatric, or social conditions that would prohibit participants from abiding by the study requirements * Physician refusal * Pregnant women * Active medical problems * History of kidney stones or any medical condition that could influence absorption or excretion of oxalate * Tobacco users * Taking medications or dietary supplements * BMI \>30 or \<20

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Urinary Oxalate Excretion

Timeframe: Days 4 and 14

Crystalluria

Timeframe: Day 4 and 14

Number of Participants With Monocyte Cellular Energetics

Timeframe: Days 4 and 14

Trial details

NCT IDNCT04051346

SponsorUniversity of Alabama at Birmingham

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-01

Results submitted2026-04-24

View on ClinicalTrials.gov More Kidney Stone trials

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.