Actively Recruiting
Gut Oxalate Absorption in Calcium Oxalate Stone Disease
Led by University of Alabama at Birmingham · Updated on 2025-05-13
80
Participants Needed
2
Research Sites
402 weeks
Total Duration
On this page
Sponsors
U
University of Alabama at Birmingham
Lead Sponsor
U
University of Texas Southwestern Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial study is to test if patients with idiopathic calcium oxalate kidney stones have an increased absorption of dietary oxalate, which would lead to increased urinary excretion of oxalate. The study will recruit adult patients with a history of calcium oxalate kidney stones and healthy volunteers without kidney stones. Participants will * ingest fixed diets containing low and moderately high amounts of oxalate for 5 days at a time * ingest a soluble form of oxalate and sugar preparations to test gut permeability * collect urine, blood, stool and breath sample during the fixed diets and the soluble oxalate test
CONDITIONS
Official Title
Gut Oxalate Absorption in Calcium Oxalate Stone Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 70 years
- Body mass index greater than 18.5 kg/m2
- Normal fasting serum electrolytes on comprehensive metabolic profile
- Willing to ingest fixed diets
- Willing to stop supplements (vitamins including vitamin C, calcium, herbal supplements, nutritional aids, probiotics) for 2 weeks before and during the study
- For stone formers: first time or recurrent calcium oxalate stone former with most recent stone composition at least 50% calcium oxalate if available and uric acid component less than 20%
You will not qualify if you...
- Chronic kidney disease stage 4 or 5
- Primary or secondary (enteric) hyperoxaluria
- Liver, bowel, endocrine, or renal diseases other than idiopathic calcium oxalate kidney stones that affect ion absorption or excretion, including cystic fibrosis, celiac disease, cystinuria, uric acid stone former, nephrotic syndrome, sarcoidosis, renal tubular acidosis, primary hyperparathyroidism, neurogenic bladder, urinary diversion, chronic diarrhea, bariatric surgery, inflammatory bowel disease
- Pregnancy or breastfeeding
- Dietary requirements incompatible with study or allergies/intolerance to study foods
- Active cancer or cancer treatment within 12 months prior to screening
- Use of immunosuppressive medication
- Uncontrolled hypertension or diabetes
- Type 1 diabetes
- Chronic use of NSAIDs
AI-Screening
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Trial Site Locations
Total: 2 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Actively Recruiting
2
UTSW
Dallas, Texas, United States, 75390
Active, Not Recruiting
Research Team
S
Sonia Fargue, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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