[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610298":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":37,"locations":46,"responsibleParty":64,"collaborators":26,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":26,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":26,"enrollmentInfo":75,"targetDuration":26,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":48,"whyStopped":26,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Icahn School of Medicine at Mount Sinai","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Empiric Therapy","EXPERIMENTAL","Patients randomized to the empiric group will receive treatment based on the pH on urinalysis and stone composition. Patients with greater than 50% calcium oxalate monohydrate (COM) stone composition will be counseled on a low oxalate diet by a medical provider. Patients with greater than 50% calcium oxalate dihydrate (COD) stone composition will be prescribed 25 mg of chlorthalidone once a day. In the rare event the stone composition is 50% COM and 50% COD, then those patients will receive both low oxalate diet counseling and a prescription for chlorthalidone.",[13,14],"Drug: Chlorthalidone","Behavioral: Low oxalate diet",{"label":16,"type":17,"description":18,"interventionNames":19},"Selective Therapy","ACTIVE_COMPARATOR","Patients randomized to the selective group will undergo medical therapy based on the American Urological Association (AUA) guidelines from the 24-hour urine collection results. Patients with idiopathic hyperoxaluria (\\> 40mg\u002Fday) will receive a low oxalate diet and receive the same dietary counseling, handout, and questionnaire as the empiric group. Patients with idiopathic hypercalciuria (\\> 250mg in men, \\>200mg in women) will be prescribed 25mg of chlorthalidone once a day.",[13,14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","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.",[9,16],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"BEHAVIORAL","Low oxalate diet","Participants receive counseling to follow a low oxalate diet, limiting high oxalate foods (\\>50 mg\u002F100 g) and restricting moderate oxalate foods (\\\u003C50 mg\u002F100 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.",[9,16],[33],{"name":34,"affiliation":35,"role":36},"Mantu Gupta, MD","Mount Sinai West","PRINCIPAL_INVESTIGATOR",[38,43],{"name":39,"role":40,"phone":41,"phoneExt":26,"email":42},"Blair Gallante, MPH","CONTACT","631-991-1159","blair.gallante@mountsinai.org",{"name":34,"role":40,"phone":44,"phoneExt":26,"email":45},"212-241-1272","mantu.gupta@mountsinai.org",[47],{"facility":35,"status":48,"city":49,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"RECRUITING","New York","10019","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-74.00597,40.71427,{"lat":57,"lon":56},[60,61,62],{"name":34,"role":40,"phone":44,"phoneExt":26,"email":45},{"name":39,"role":40,"phone":41,"phoneExt":26,"email":42},{"name":63,"role":36,"phone":26,"phoneExt":26,"email":26},"Mantu Gupta",{"type":36,"investigatorFullName":63,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Chair of Urology, MSW and MSM Hospitals Professor, Icahn School of Medicine at Mount Sinai Director of Endourology, Mount Sinai Medical Center","100610298","phase-4-caox-stone-prevention-100610298",false,"NCT07225764","CaOx Stone Prevention","Empiric vs Selective Medical Therapy for Calcium Oxalate Stone Prevention: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Adult age of 18 years\n* Diagnosed with kidney stones and scheduled for PCNL.\n* Calcium Oxalate Stone Former\n* Pre-operative CT-scan within 90 days of surgery and stone density with \\> 1000 Hounsfield units\n* Non-pregnant or breastfeeding\n* Able and willing to provide informed consent.\n* Pre-operative eGFR greater than 70 mL\u002Fmin\u002F1.73 m² -Negative pre-operative urine culture\n\nExclusion Criteria:\n\n* Documented history of gastric or intestinal bypass, liver disease, history of gastrointestinal malabsorptive disease (Crohn's disease, ulcerative colitis, and short-gut syndrome)\n* Hyperparathyroidism -Renal tubular acidosis\n* Active kidney stone prevention treatment (use of thiazides, alkaline therapy, or low oxalate diet) at the time of surgery\n* History of hypokalemia or baseline hypotension\n* Allergy to medications used in trial or sulfa-containing medications\n* Patient prescribed thiazide, loop diuretics, carbonic anhydrase inhibitors, xanthine oxidase inhibitors, active Vitamin D, bisphosphonates, denosumab, glucocorticoids, or potassium supplementation","ALL","18 Years",{"count":76,"type":77},80,"ESTIMATED","INTERVENTIONAL",[80],"PHASE4","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.",[83],"Kidney Stones",[85,86,87],"kidney stones","calcium oxalate","nephrolithiasis","2025-11-05",{"date":90,"type":91},"2025-11-10","ACTUAL",{"date":93,"type":91},"2025-10-23",{"date":95,"type":77},"2027-06-30",{"name":5,"class":6},1]