Recruiting

Observational StudyOxalate-Driven Host Responses in Kidney Stone Disease

Sponsor:

University of Alabama at Birmingham

Code:

NCT05417568

Conditions

Kidney Stones

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

Interventions

Low Oxalate Diet

High Oxalate Diet

Study Details

Brief summary:

This study is looking to understand the role of oxalate on kidney stone development and immunity. This study will enroll healthy participants and participants with calcium oxalate kidney stones (CaOx KS). Participants will be in this study for about 3 weeks, consume controlled diets, and provide blood and urine specimens.

Conditions

Kidney Stones

Study ID

NCT05417568

Start date

May 19, 2023

Status verified date

May, 2026

Completion date

May 30, 2027

Anticipated

Primary completion date

May 30, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

88 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Healthy Participants

Healthy participants will randomly receive either high (250mg) or low (40mg) oxalate diet for for four days, a ten day "washout" period on a self-selected diet, and finally the opposite diet from the first for the last four days.

experimental: Calcium Oxalate Kidney Stone

Calcium oxalate kidney stone participants will randomly receive either high (250mg) or low (40mg) oxalate diet for for four days, a ten day "washout" period on a self-selected diet, and finally the opposite diet from the first for the last four days.

Interventions

Low Oxalate Diet

Participants will consume a diet that is controlled in its daily contents of oxalate and calcium, and in its content of carbohydrate, fat, and protein. Participants will be asked not to take any dietary supplements, exercise strenuously, or consume food or drink that is not provided to them.

High Oxalate Diet

Primary outcome measure

Change in Urinary Oxalate [ Time Frame: Days 3-4 and 13-14 ]
Change in Nanocystalluria [ Time Frame: Days 3-4 and 13-14 ]
Monocyte Cellular Bioenergetics and Mitochondrial Function [ Time Frame: Day 1 ]
Monocyte Cellular Bioenergetics and Mitochondrial Function [ Time Frame: Day 4 ]
Monocyte Cellular Bioenergetics and Mitochondrial Function [ Time Frame: Day 11 ]
Monocyte Cellular Bioenergetics and Mitochondrial Function [ Time Frame: Day 14 ]
Monocyte Subtypes [ Time Frame: Day 1 ]
Monocyte Subtypes [ Time Frame: Day 4 ]
Monocyte Subtypes [ Time Frame: Day 11 ]
Monocyte Subtypes [ Time Frame: Day 14 ]
Monocyte Transcriptomics [ Time Frame: Day 1 ]
Monocyte Transcriptomics [ Time Frame: Day 4 ]
Monocyte Transcriptomics [ Time Frame: Day 11 ]
Monocyte Transcriptomics [ Time Frame: Day 14 ]

Central Contacts and Locations

Central contacts

Tanecia Mitchell, PhD

(205) 996-2292 taneciamitchell@uabmc.edu

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

Tanecia Mitchell, PhD

(205) 996-2292 taneciamitchell@uabmc.edu

Principal Investigator:

Tanecia Mitchell, PhD

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

May 15, 2026

Last verified

May, 2026

Keywords

Kidney stones
Dietary oxalate

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-05-15.