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CaOx Stone Prevention
Sponsor: Icahn School of Medicine at Mount Sinai
Summary
This single-center randomized controlled trial at Mount Sinai West will enroll 80 patients undergoing percutaneous nephrolithotomy for calcium oxalate stones. Participants will be randomized to receive either empiric therapy or selective therapy guided by 24-hour urine evaluation. The primary outcome is change in calcium oxalate supersaturation at 4 weeks, aiming to determine whether empiric therapy can provide outcomes comparable to selective therapy while simplifying access to prevention.
Official title: Empiric vs Selective Medical Therapy for Calcium Oxalate Stone Prevention: A Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2025-10-23
Completion Date
2027-06-30
Last Updated
2025-11-10
Healthy Volunteers
No
Conditions
Interventions
Chlorthalidone
Chlorthalidone 25 mg orally once daily is used to reduce urinary calcium excretion and prevent recurrent calcium-containing kidney stones. In this study, it is prescribed either based on stone composition (empiric group) or guided by 24-hour urine results (selective group) for participants meeting criteria for hypercalciuria or calcium oxalate dihydrate stones.
Low oxalate diet
Participants receive counseling to follow a low oxalate diet, limiting high oxalate foods (\>50 mg/100 g) and restricting moderate oxalate foods (\<50 mg/100 g) to a single four-ounce serving per day. The diet is prescribed either based on stone composition (empiric group) or guided by 24-hour urine results (selective group) for participants with idiopathic hyperoxaluria or calcium oxalate monohydrate stones.
Locations (1)
Mount Sinai West
New York, New York, United States