Kidney StoneNCT04605055
The Interplay Between Oxalate, Immunity and Infection
A study testing Low Oxalate Diet and High Oxalate Diet in people with Kidney Stone, run by University of Alabama at Birmingham.
Trial summary
This study consists of having subjects, those with calcium oxalate kidney stones as well as healthy controls, consume low and oxalate enriched diets to investigate the role of oxalate on crystalluria (the presence of crystals in urine), immunity and infection. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Kidney Stone
- 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
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2025to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Able to provide informed consent
- Body Mass Index (BMI) between 20-30 kg/m2
- Non tobacco users or not pregnant/breast feeding/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 appropriate ratio of creatinine (mg)/body weight (kg) for gender
- Healthy subjects: No history of calcium oxalate kidney stones (CaOx KS) or other medical conditions
- Patients with CaOx KS: Recent stone composition greater than 50% CaOx; no uric acid or struvite stone content must be present. Must be first time or recurrent CaOx stone former (last stone event within the past 3 years)
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- 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 University of Alabama Center for Clinical and Translational Science 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 kidney stone 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 anti-oxidant 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 to the study requirements
- BMI greater than 30 kg/m2 or less than 20 kg/m2
- Tobacco users or pregnant or breast feeding/nursing women
- Abnormal fasting blood comprehensive metabolic panel, complete blood count, C-reactive protein, and urinalysis. Inaccurate 24-hour urine collections.
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- Healthy subjects: Taking medications or dietary supplements. History of kidney stones 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.
- Active disease including diabetes, gout, hypertension, primary hyperoxaluria, nephrotic syndrome, enteric hyperoxaluria, renal tubular acidosis, primary hyperparathyroidism, liver disease, autoimmune disorder, neurogenic bladder, urinary diversion, and bariatric surgery.
- Active malignancy or treatment for malignancy within 12 months prior to screening.
About this study
This study consists of having subjects, those with calcium oxalate kidney stones as well as healthy controls, consume low and oxalate enriched diets to investigate the role of oxalate on crystalluria (the presence of crystals in urine), immunity and infection.
- Conditions
- Kidney Stone
- Being tested
- Low Oxalate Diet, High Oxalate Diet
- Keywords
- 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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Low Oxalate Diet Followed by High Oxalate Diet | Experimental | Subjects will consume a low oxalate diet for four days, with blood collections on Days 1 and 4 and 24-hour urine collections on Days 3 and 4. A ten day wash out period will follow, during which participants will consume their normal diet. After the wash out period, subjects will consume a high oxalate diet for four days, with blood and 24-hour urine collections occurring again as described previously. Receives: Dietary Supplement: Low Oxalate Diet; Dietary Supplement: High Oxalate Diet |
| High Oxalate Diet Followed by Low Oxalate Diet | Experimental | Subjects will consume a high oxalate diet for four days, with blood collections on Days 1 and 4 and 24-hour urine collections on Days 3 and 4. A ten day wash out period will follow, during which participants will consume their normal diet. After the wash out period, subjects will consume a low oxalate diet for four days, with blood and 24-hour urine collections occurring again as described previously. 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.
Urinary Oxalate
Twenty-four hour urinary oxalate will be reported as mg/day
Measured: Change between Baseline and Diets at 4 days
Crystalluria
Twenty-four hour crystalluria will be reported as particles/ml
Measured: Change between Baseline and Diets at 4 days
Monocyte Cellular Bioenergetics
Cellular bioenergetics will be reported as oxygen consumption rate
Measured: Change between Baseline and Diets at 4 days
Monocyte Mitochondrial Complex Activity
Monocyte mitochondrial complex activity will be reported as oxygen consumption rate
Measured: Change between Baseline and Diets at 4 days
Monocyte Transcriptomics
Monocyte transcriptomics will be reported as gene expression (mRNA levels)
Measured: Change between Baseline and Diets at 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2020
- Study start1 Jun 2025 (estimated)
- Primary completion30 Oct 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Why it stopped: This study was not started due to shift in research efforts and funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney StoneStudies 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
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- 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
- NCT04605055
- Sponsor's protocol ID
- IRB-300005965
- Status last verified
- Jun 2025
- First submitted
- 12 Oct 2020
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Interplay Between Oxalate, Immunity and Infection
- ClinicalTrials.gov ID
- NCT04605055
- Acronym / sponsor ID
- IRB-300005965
- Conditions
- Kidney Stone
- Keywords
- Oxalate
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study was not started due to shift in research efforts and funding.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 27 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study consists of having subjects, those with calcium oxalate kidney stones as well as healthy controls, consume low and oxalate enriched diets to investigate the role of oxalate on crystalluria (the presence of crystals in urine), immunity and infection.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Oxalate Diet Followed by High Oxalate Diet | Experimental | Dietary Supplement: Low Oxalate Diet, Dietary Supplement: High Oxalate DietSubjects will consume a low oxalate diet for four days, with blood collections on Days 1 and 4 and 24-hour urine collections on Days 3 and 4. A ten day wash out period will follow, during which participants will consume their normal diet. After the wash out period, subjects will consume a high oxalate diet for four days, with blood and 24-hour urine collections occurring again as described previously. |
| High Oxalate Diet Followed by Low Oxalate Diet | Experimental | Dietary Supplement: Low Oxalate Diet, Dietary Supplement: High Oxalate DietSubjects will consume a high oxalate diet for four days, with blood collections on Days 1 and 4 and 24-hour urine collections on Days 3 and 4. A ten day wash out period will follow, during which participants will consume their normal diet. After the wash out period, subjects will consume a low oxalate diet for four days, with blood and 24-hour urine collections occurring again as described previously. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Able to provide informed consent
- Body Mass Index (BMI) between 20-30 kg/m2
- Non tobacco users or not pregnant/breast feeding/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 appropriate ratio of creatinine (mg)/body weight (kg) for gender
- Healthy subjects: No history of calcium oxalate kidney stones (CaOx KS) or other medical conditions
Key exclusion criteria (10 listed)
- 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 to the study requirements
- BMI greater than 30 kg/m2 or less than 20 kg/m2
- Tobacco users or pregnant or breast feeding/nursing women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Oxalate DietParticipants will consume a diet that is controlled in its daily contents of oxalate and calcium, and in its content of carbohydrate, fat, and protein. | Dietary supplement | High Oxalate Diet Followed by Low Oxalate Diet, Low Oxalate Diet Followed by High Oxalate Diet |
| High Oxalate DietParticipants will consume a diet that is controlled in its daily contents of oxalate and calcium, and in its content of carbohydrate, fat, and protein. | Dietary supplement | High Oxalate Diet Followed by Low Oxalate Diet, Low Oxalate Diet Followed by High Oxalate Diet |
Primary outcome
Urinary Oxalate
Time frame: Change between Baseline and Diets at 4 days
Twenty-four hour urinary oxalate will be reported as mg/day
Crystalluria
Time frame: Change between Baseline and Diets at 4 days
Twenty-four hour crystalluria will be reported as particles/ml
Monocyte Cellular Bioenergetics
Time frame: Change between Baseline and Diets at 4 days
Cellular bioenergetics will be reported as oxygen consumption rate
Monocyte Mitochondrial Complex Activity
Time frame: Change between Baseline and Diets at 4 days
Monocyte mitochondrial complex activity will be reported as oxygen consumption rate
Monocyte Transcriptomics
Time frame: Change between Baseline and Diets at 4 days
Monocyte transcriptomics will be reported as gene expression (mRNA levels)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tanecia Mitchell, PhD principal investigator
University of Alabama at Birmingham
Questions about this trial
What is this clinical trial studying?
A study testing Low Oxalate Diet and High Oxalate Diet in people with Kidney Stone, run by University of Alabama at Birmingham.
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 11 inclusion and 10 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: withdrawn, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary Oxalate (time frame: Change between Baseline and Diets at 4 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jun 2025.