Actively Recruiting
Oxalate-Driven Host Responses in Kidney Stone Disease
Led by University of Alabama at Birmingham · Updated on 2025-05-06
88
Participants Needed
1
Research Sites
210 weeks
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
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.
CONDITIONS
Official Title
Oxalate-Driven Host Responses in Kidney Stone Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women aged 18 to 60 years old
- Able to provide informed consent
- BMI between 20 and 30 kg/m2
- Non-tobacco users and not pregnant or breastfeeding
- Normal fasting blood tests including metabolic panel, blood count, C-reactive protein, and urinalysis
- Accurate collection of two 24-hour urine samples within 20% of expected creatinine/body weight ratio
- Healthy subjects with no history of calcium oxalate kidney stones or other medical conditions
- Patients with calcium oxalate kidney stones having recent stone composition over 50% calcium oxalate and no other stone types
- First-time or recurrent calcium oxalate stone formers with last stone event within 3 years
- Willing to avoid supplements and vigorous exercise during the study
- Willing to consume only study-provided diets without food allergies or intolerances
- Willing to provide urine and blood samples throughout the study
- Patients on stable doses of kidney stone prevention medications for at least 8 weeks prior, excluding allopurinol for 2 weeks before screening
You will not qualify if you...
- Failure to meet inclusion criteria or physician refusal
- Unable to read or sign informed consent
- Medical, psychiatric, or social conditions preventing study compliance
- BMI less than 20 or greater than 30 kg/m2
- Tobacco users or pregnant or breastfeeding women
- Abnormal fasting blood or urine tests
- Inaccurate 24-hour urine collections
- Healthy subjects who have recently taken antibiotics, supplements, or have history of kidney stones or medical conditions affecting oxalate
- 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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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