Kidney StonesNCT05417568
Oxalate-Driven Host Responses in Kidney Stone Disease
A study testing Low Oxalate Diet and High Oxalate Diet in people with Kidney Stones, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Kidney Stones
- What is being tested?
- Low Oxalate Diet and High Oxalate Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 19 May 2023to 30 May 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Tanecia Mitchell, PhD, (205) 996-2292, taneciamitchell@uabmc.edu
Tanecia Mitchell, PhD
About this study
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.
Read the detailed description
The purpose of this longitudinal study is to examine the effects of dietary oxalate on nanocrystalluria and the immune system. Oxalate is a small molecule found in plants and plant-derived food. It has been shown that meals containing high amounts of oxalate can increase urinary oxalate excretion, which is a risk factor for calcium oxalate kidney stones (CaOx KS). Small increases in oxalate can stimulate urinary crystals to form which can elicit an immune response. This study consists of having healthy subjects and patients with CaOx KS consume both low and oxalate enriched diets to evaluate the effect of oxalate on urinary crystals and immune responses. Participants will receive a low or high oxalate diet for 4 days prior to having a wash-out period for 6 days. Participants will then crossover to the opposite oxalate diet for four more days.
- Conditions
- Kidney Stones
- Being tested
- Low Oxalate Diet, High Oxalate Diet
- Keywords
- Kidney stones, Dietary oxalate
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Oxalate DietDietary supplement
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 DietDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Participants | Experimental | 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. Receives: Dietary Supplement: Low Oxalate Diet; Dietary Supplement: High Oxalate Diet |
| Calcium Oxalate Kidney Stone | Experimental | 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. Receives: Dietary Supplement: Low Oxalate Diet; Dietary Supplement: High Oxalate Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Urinary Oxalate
Twenty-four hour urinary oxalate will be reported as mg/day.
Measured: Days 3-4 and 13-14
Change in Nanocystalluria
Nanocrystalluria will be reported as particles/ml.
Measured: Days 3-4 and 13-14
Monocyte Cellular Bioenergetics and Mitochondrial Function
Cellular bioenergetics and mitochondrial function will be reported as oxygen consumption rate (pmol/min/10,000 cells).
Measured: Day 1
Monocyte Cellular Bioenergetics and Mitochondrial Function
Cellular bioenergetics and mitochondrial function will be reported as oxygen consumption rate (pmol/min/10,000 cells).
Measured: Day 4
Monocyte Cellular Bioenergetics and Mitochondrial Function
Cellular bioenergetics and mitochondrial function will be reported as oxygen consumption rate (pmol/min/10,000 cells).
Measured: Day 11
Monocyte Cellular Bioenergetics and Mitochondrial Function
Cellular bioenergetics and mitochondrial function will be reported as oxygen consumption rate (pmol/min/10,000 cells).
Measured: Day 14
Monocyte Subtypes
Monocyte subtypes will be determined using flow cytometry (mean fluorescence intensity).
Measured: Day 1
Monocyte Subtypes
Monocyte subtypes will be determined using flow cytometry (mean fluorescence intensity).
Measured: Day 4
Monocyte Subtypes
Monocyte subtypes will be determined using flow cytometry (mean fluorescence intensity).
Measured: Day 11
Monocyte Subtypes
Monocyte subtypes will be determined using flow cytometry (mean fluorescence intensity).
Measured: Day 14
Monocyte Transcriptomics
Monocyte transcriptomics will be reported as gene expression (mRNA levels)
Measured: Day 1
Monocyte Transcriptomics
Monocyte transcriptomics will be reported as gene expression (mRNA levels)
Measured: Day 4
Monocyte Transcriptomics
Monocyte transcriptomics will be reported as gene expression (mRNA levels)
Measured: Day 11
Monocyte Transcriptomics
Monocyte transcriptomics will be reported as gene expression (mRNA levels)
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start19 May 2023
- Primary completion30 May 2027 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney StonesStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, Tanecia Mitchell, PhD, University of Alabama at Birmingham
- Investigators
- Tanecia Mitchell, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05417568
- Sponsor's protocol ID
- IRB-300009093
- Other IDs
- R01DK129885
- Status last verified
- May 2026
- First submitted
- 6 Jun 2022
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No