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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
Are there results?
Not yet: the study is under way

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.
Show all 12Show fewer
  • 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.

Tanecia Mitchell, PhD contact

(205) 996-2292

taneciamitchell@uabmc.edu

United States1 site, 1 recruiting

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

    Tanecia Mitchell, PhD, (205) 996-2292, taneciamitchell@uabmc.edu

    Tanecia Mitchell, PhD

    Recruiting

Other trials in United States

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 groups in NCT05417568
Study groupRoleWhat they receive
Healthy ParticipantsExperimentalHealthy 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 StoneExperimentalCalcium 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.

  1. Change in Urinary Oxalate

    Twenty-four hour urinary oxalate will be reported as mg/day.

    Measured: Days 3-4 and 13-14

  2. Change in Nanocystalluria

    Nanocrystalluria will be reported as particles/ml.

    Measured: Days 3-4 and 13-14

  3. 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

  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 4

  5. 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

  6. 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

  7. Monocyte Subtypes

    Monocyte subtypes will be determined using flow cytometry (mean fluorescence intensity).

    Measured: Day 1

  8. Monocyte Subtypes

    Monocyte subtypes will be determined using flow cytometry (mean fluorescence intensity).

    Measured: Day 4

  9. Monocyte Subtypes

    Monocyte subtypes will be determined using flow cytometry (mean fluorescence intensity).

    Measured: Day 11

  10. Monocyte Subtypes

    Monocyte subtypes will be determined using flow cytometry (mean fluorescence intensity).

    Measured: Day 14

  11. Monocyte Transcriptomics

    Monocyte transcriptomics will be reported as gene expression (mRNA levels)

    Measured: Day 1

  12. Monocyte Transcriptomics

    Monocyte transcriptomics will be reported as gene expression (mRNA levels)

    Measured: Day 4

  13. Monocyte Transcriptomics

    Monocyte transcriptomics will be reported as gene expression (mRNA levels)

    Measured: Day 11

  14. 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.

  1. First posted14 Jun 2022
  2. Study start19 May 2023
  3. Primary completion30 May 2027 (estimated)
  4. Study completion30 May 2027 (estimated)

Resources

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)
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

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Tanecia Mitchell, PhD ((205) 996-2292, taneciamitchell@uabmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Urinary Oxalate (time frame: Days 3-4 and 13-14). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05417568.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.

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