RecruitingPhase 4NCT07225764

CaOx Stone Prevention

Empiric vs Selective Medical Therapy for Calcium Oxalate Stone Prevention: A Randomized Controlled Trial

Sponsor

Icahn School of Medicine at Mount Sinai

Enrollment

80 participants

Start Date

Oct 23, 2025

Study Type

INTERVENTIONAL

Conditions

Kidney Stones

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Chlorthalidone and a behavioral approach called Low oxalate diet for people with kidney stones. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGChlorthalidone

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.

BEHAVIORALLow 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.