- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05417568
Oxalate-Driven Host Responses in Kidney Stone Disease
May 31, 2023 updated by: Tanecia Mitchell, PhD, University of Alabama at Birmingham
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
88
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Tanecia Mitchell, PhD
- Phone Number: (205) 996-2292
- Email: taneciamitchell@uabmc.edu
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35294
- Recruiting
- University of Alabama at Birmingham
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Contact:
- Tanecia Mitchell, PhD
- Phone Number: 205-996-2292
- Email: taneciamitchell@uabmc.edu
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Principal Investigator:
- Tanecia Mitchell, PhD
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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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.
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.
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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.
|
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.
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Urinary Oxalate
Time Frame: Days 3-4 and 13-14
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Twenty-four hour urinary oxalate will be reported as mg/day.
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Days 3-4 and 13-14
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Change in Nanocystalluria
Time Frame: Days 3-4 and 13-14
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Nanocrystalluria will be reported as particles/ml.
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Days 3-4 and 13-14
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Monocyte Cellular Bioenergetics and Mitochondrial Function
Time Frame: Day 1
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Cellular bioenergetics and mitochondrial function will be reported as oxygen consumption rate (pmol/min/10,000 cells).
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Day 1
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Monocyte Cellular Bioenergetics and Mitochondrial Function
Time Frame: Day 4
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Cellular bioenergetics and mitochondrial function will be reported as oxygen consumption rate (pmol/min/10,000 cells).
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Day 4
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Monocyte Cellular Bioenergetics and Mitochondrial Function
Time Frame: Day 11
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Cellular bioenergetics and mitochondrial function will be reported as oxygen consumption rate (pmol/min/10,000 cells).
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Day 11
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Monocyte Cellular Bioenergetics and Mitochondrial Function
Time Frame: Day 14
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Cellular bioenergetics and mitochondrial function will be reported as oxygen consumption rate (pmol/min/10,000 cells).
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Day 14
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Monocyte Subtypes
Time Frame: Day 1
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Monocyte subtypes will be determined using flow cytometry (mean fluorescence intensity).
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Day 1
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Monocyte Subtypes
Time Frame: Day 4
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Monocyte subtypes will be determined using flow cytometry (mean fluorescence intensity).
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Day 4
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Monocyte Subtypes
Time Frame: Day 11
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Monocyte subtypes will be determined using flow cytometry (mean fluorescence intensity).
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Day 11
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Monocyte Subtypes
Time Frame: Day 14
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Monocyte subtypes will be determined using flow cytometry (mean fluorescence intensity).
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Day 14
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Monocyte Transcriptomics
Time Frame: Day 1
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Monocyte transcriptomics will be reported as gene expression (mRNA levels)
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Day 1
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Monocyte Transcriptomics
Time Frame: Day 4
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Monocyte transcriptomics will be reported as gene expression (mRNA levels)
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Day 4
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Monocyte Transcriptomics
Time Frame: Day 11
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Monocyte transcriptomics will be reported as gene expression (mRNA levels)
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Day 11
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Monocyte Transcriptomics
Time Frame: Day 14
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Monocyte transcriptomics will be reported as gene expression (mRNA levels)
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Day 14
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Tanecia Mitchell, PhD, University of Alabama at Birmingham
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 19, 2023
Primary Completion (Estimated)
May 30, 2027
Study Completion (Estimated)
May 30, 2027
Study Registration Dates
First Submitted
June 6, 2022
First Submitted That Met QC Criteria
June 8, 2022
First Posted (Actual)
June 14, 2022
Study Record Updates
Last Update Posted (Actual)
June 1, 2023
Last Update Submitted That Met QC Criteria
May 31, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-300009093
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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