Oxalate-Driven Host Responses in Kidney Stone Disease
2 other identifiers
interventional
88
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 6, 2022
CompletedFirst Posted
Study publicly available on registry
June 14, 2022
CompletedStudy Start
First participant enrolled
May 19, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 30, 2027
May 6, 2025
May 1, 2025
4 years
June 6, 2022
May 5, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (14)
Change in Urinary Oxalate
Twenty-four hour urinary oxalate will be reported as mg/day.
Days 3-4 and 13-14
Change in Nanocystalluria
Nanocrystalluria will be reported as particles/ml.
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).
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).
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).
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).
Day 14
Monocyte Subtypes
Monocyte subtypes will be determined using flow cytometry (mean fluorescence intensity).
Day 1
Monocyte Subtypes
Monocyte subtypes will be determined using flow cytometry (mean fluorescence intensity).
Day 4
Monocyte Subtypes
Monocyte subtypes will be determined using flow cytometry (mean fluorescence intensity).
Day 11
Monocyte Subtypes
Monocyte subtypes will be determined using flow cytometry (mean fluorescence intensity).
Day 14
Monocyte Transcriptomics
Monocyte transcriptomics will be reported as gene expression (mRNA levels)
Day 1
Monocyte Transcriptomics
Monocyte transcriptomics will be reported as gene expression (mRNA levels)
Day 4
Monocyte Transcriptomics
Monocyte transcriptomics will be reported as gene expression (mRNA levels)
Day 11
Monocyte Transcriptomics
Monocyte transcriptomics will be reported as gene expression (mRNA levels)
Day 14
Study Arms (2)
Healthy Participants
EXPERIMENTALHealthy 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.
Calcium Oxalate Kidney Stone
EXPERIMENTALCalcium 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
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tanecia Mitchell, PhD
University of Alabama at Birmingham
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 6, 2022
First Posted
June 14, 2022
Study Start
May 19, 2023
Primary Completion (Estimated)
May 30, 2027
Study Completion (Estimated)
May 30, 2027
Last Updated
May 6, 2025
Record last verified: 2025-05