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Oxalate-Driven Host Responses in Kidney Stone Disease
Led by University of Alabama at Birmingham · Updated on 2026-05-15
88
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Alabama at Birmingham
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the role of oxalate, a molecule found in plants and plant-based foods, in the development of calcium oxalate kidney stones and how it affects the immune system. This study involves both healthy participants and those with calcium oxalate kidney stones (CaOx KS) to better understand how dietary oxalate influences urinary crystals and immune responses. The study focuses on how small increases in oxalate can lead to urinary crystal formation and trigger immune reactions. Participants will follow controlled diets with either low (40mg) or high (250mg) oxalate content for four days, then have a ten-day washout period where they eat their usual food, followed by switching to the opposite diet for another four days. Both healthy participants and those with CaOx KS will be randomly assigned to start with either the low or high oxalate diet. During the study, participants will avoid dietary supplements, strenuous exercise, and foods or drinks not provided by the study team. Over about three weeks, participants will provide blood and urine samples, including two 24-hour urine collections, to monitor changes in urinary oxalate levels, nanocrystalluria (tiny urinary crystals), and immune cell function. Researchers will assess monocyte bioenergetics, mitochondrial function, subtypes, and gene activity at multiple time points. The study includes careful monitoring of diet adherence and immune responses to better understand oxalate's impact on kidney stone development and immunity.
CONDITIONS
Brief Title
Oxalate-Driven Host Responses in Kidney Stone Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women between the ages of 18 and 60 years old.
- Able to provide informed consent.
- Body mass index (BMI) between 20 and 30 kg/m2.
- Non-tobacco users and not pregnant, breastfeeding, or nursing.
- Normal fasting blood tests including metabolic panel, blood count, C-reactive protein, and urinalysis.
- Ability to accurately collect two 24-hour urine samples within 20% of the appropriate creatinine to body weight ratio for gender.
- Healthy subjects have no history of calcium oxalate kidney stones or other medical conditions.
- Patients with calcium oxalate kidney stones have a recent stone composition over 50% calcium oxalate, no other stone types, and their last stone event occurred within 3 years.
- Willingness to avoid supplements such as vitamins, calcium, minerals, herbal supplements, nutritional aids, and probiotics for 2 weeks before and during the study.
- Willingness to abstain from vigorous exercise during the study.
- Willingness to consume only provided study diets with no food allergies or intolerances to the menu.
- Willingness to accurately collect 24-hour urine samples and provide blood samples during the study.
- Patients on medications for kidney stone prevention must be on a stable regimen for at least 8 weeks prior and during screening, and avoid allopurinol for 2 weeks before screening.
You will not qualify if you...
- Failure to meet inclusion criteria or refusal by physician.
- Inability to read or sign informed consent.
- Medical, psychiatric, or social conditions preventing adherence to study requirements.
- BMI less than 20 kg/m2 or greater than 30 kg/m2.
- Tobacco users or pregnant, breastfeeding, or nursing women.
- Abnormal fasting blood tests or inaccurate 24-hour urine collections.
- Healthy subjects currently or recently taking medications or supplements influencing oxalate absorption or excretion.
- History of kidney stones or medical conditions affecting oxalate in healthy subjects.
- Active illness such as COVID-19, flu, cold, fever, diarrhea, urinary tract infections, or other infections within 14 days before or during the study.
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Participants undergo screening assessments including blood tests and urine collections to determine eligibility.
Duration - 4 days
Participants consume a controlled low oxalate diet for 4 days while avoiding supplements, strenuous exercise, and any food or drink not provided by the study.
Participants follow the diet at home with dietary guidance; urine and blood samples are collected on Days 1 and 4.
Duration - 10 days
Participants follow a self-selected diet for 10 days to wash out the effects of the first diet phase.
No study visits; participants maintain their usual diet.
Duration - 4 days
Participants consume a controlled high oxalate diet for 4 days while avoiding supplements, strenuous exercise, and any food or drink not provided by the study.
Participants follow the diet at home with dietary guidance; urine and blood samples are collected on Days 11 and 14.
Trial Site Locations
Total: 1 location
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Actively Recruiting
Research Team
T
Tanecia Mitchell, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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