[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624318":3},{"organization":4,"outcomesModule":7,"designInfo":24,"detailedDescription":32,"studyPopulation":29,"armGroups":33,"interventions":45,"overallOfficials":55,"centralContacts":59,"locations":64,"responsibleParty":137,"collaborators":140,"id":149,"slug":150,"hasResults":151,"nctId":152,"briefTitle":153,"officialTitle":153,"acronym":29,"eligibilityCriteria":154,"healthyVolunteers":151,"sex":155,"minAge":156,"maxAge":29,"enrollmentInfo":157,"targetDuration":29,"studyType":160,"phases":161,"briefSummary":164,"conditions":165,"keywords":168,"overallStatus":176,"whyStopped":29,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":186},{"fullName":5,"class":6},"University of California, Los Angeles","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":20},[9],{"measure":10,"description":11,"timeFrame":12},"Change in 24-Hour Urinary Citrate Excretion from 24-Hour Urine Collection","Change in 24-hour urinary citrate excretion measured from 24-hour urine collections obtained at baseline and after intervention.\n\nTo determine if sodium bicarbonate is not significantly worse than potassium citrate by more than a clinically acceptable margin of -10\n\nUnit: mg\u002Fday","14 days",[14,17],{"measure":15,"description":16,"timeFrame":12},"Change in Urine pH Measured from 24-Hour Urine Collection","Change in urine pH measured from 24 hour urine collections obtained at baseline and after intervention\n\nunits: pH",{"measure":18,"description":19,"timeFrame":12},"Change in 24 hour Urinary Ammonia Excretion from 24 Hour Urine Collection","Change in 24 hour urinary ammonia excretion from 24 hour urine collections obtained at baseline and after intervention\n\nUnit: mmol\u002Fday",[21],{"measure":22,"description":23,"timeFrame":12},"Incidence of Side Effects","Number of participants experiencing side effects attributed to the intervention\n\nUnit: number of participants with ≥1 adverse event",{"allocation":25,"interventionModel":26,"interventionModelDescription":27,"primaryPurpose":28,"observationalModel":29,"timePerspective":29,"maskingInfo":30},"RANDOMIZED","CROSSOVER","1. Patients with confirmed hypocitraturia identified and enrolled in study\n2. Pre-study medical history and laboratory data will be recorded, and 24 hour urine will be obtained\n3. Set diet will be followed x 48hrs while on first treatment (sodium bicarbonate or potassium citrate; order randomized for 50:50 chance) for at least 1 week\n4. 24 Hour urine performed during 2nd day of set diet\n5. 1 week washout\n6. 1 week use of other medication (sodium bicarbonate or potassium citrate)\n7. Set diet will be followed x 48hrs while on potassium citrate\n8. 24 Hour urine performed during 2nd day of set diet\n9. Change in citrate, pH, and ammonia will be recorded.","TREATMENT",null,{"masking":31,"maskingDescription":29,"whoMasked":29},"NONE","Kidney stones affect 1 in every 11 people in the United States each year. A recurrence rate of 50% at 10 years highlights the importance of metabolic management, which has shown to be effective at decreasing the recurrence of stone disease. Specialty guidelines have recommended that clinicians offer pharmacologic therapy to recurrent stone formers. However, among kidney stone patients prescribed medication for stone management, only 30.2% are adherent to a medication regimen and even fewer, only 13.4%, are adherent with citrate medications.\n\nPrescription potassium citrate (Kcit) can be cost-prohibitive for many patients, leading to non-compliance. The combination of the effectiveness of medication with the prohibitory cost of the prescriptions has led to the exploration of treatment alternatives which promise to alkalinize the urine and\u002For decrease the risk of future kidney stones, including sodium bicarbonate. However, the efficacy of these alternatives in comparison to Kcit are not well studied and often include other alkali equivalents.\n\nA short-term study with limited sample size suggests sodium bicarbonate to be a viable alternative to Kcit. Our goal is to evaluate sodium bicarbonate and assess its ability to alkalinize urine in a cohort of stone-forming patients and compare this to prescription Kcit.",[34,41],{"label":35,"type":36,"description":37,"interventionNames":38},"Sodium Bicarbonate -> Potassium Citrate","EXPERIMENTAL","Receives 1 week of sodium bicarbonate, then 1 week of potassium citrate after washout.",[39,40],"Drug: Potassium Citrate","Drug: Sodium Bicarbonate",{"label":42,"type":36,"description":43,"interventionNames":44},"Potassium Citrate -> Sodium Bicarbonate","1 week of potassium citrate first, then sodium bicarbonate after a washout.",[39,40],[46,51],{"type":47,"name":48,"description":49,"armGroupLabels":50,"otherNames":29},"DRUG","Potassium Citrate","20 mEq Kcit twice a day (40 mEq daily",[42,35],{"type":47,"name":52,"description":53,"armGroupLabels":54,"otherNames":29},"Sodium Bicarbonate","650 mg sodium bicarbonate twice a day (35.2 mEq daily)",[42,35],[56],{"name":57,"affiliation":5,"role":58},"Kymora B Scotland, MD, PhD","PRINCIPAL_INVESTIGATOR",[60],{"name":61,"role":62,"phone":29,"phoneExt":29,"email":63},"Janelly B Jimenez","CONTACT","JBJimenez@mednet.ucla.edu",[65,77,89,101,114,124],{"facility":5,"status":29,"city":66,"state":67,"zip":68,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":29},"Los Angeles","California","90095","United States","US",{"type":72,"coordinates":73},"Point",[74,75],-118.24368,34.05223,{"lat":75,"lon":74},{"facility":78,"status":29,"city":79,"state":67,"zip":80,"country":69,"countryCode":70,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"University of California, Davis","Sacramento","95817",{"type":72,"coordinates":82},[83,84],-121.4944,38.58157,{"lat":84,"lon":83},[87],{"name":88,"role":62,"phone":29,"phoneExt":29,"email":29},"Noah Canvasser",{"facility":90,"status":29,"city":91,"state":67,"zip":92,"country":69,"countryCode":70,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"University of California, San Diego","San Diego","92103",{"type":72,"coordinates":94},[95,96],-117.16472,32.71571,{"lat":96,"lon":95},[99],{"name":100,"role":62,"phone":29,"phoneExt":29,"email":29},"Seth Bechis",{"facility":102,"status":29,"city":103,"state":104,"zip":105,"country":69,"countryCode":70,"cosmosGeoPoint":106,"geoPoint":110,"contacts":111},"Brigham & Women's","Boston","Massachusetts","02115",{"type":72,"coordinates":107},[108,109],-71.05977,42.35843,{"lat":109,"lon":108},[112],{"name":113,"role":62,"phone":29,"phoneExt":29,"email":29},"Daniel Wolen",{"facility":115,"status":29,"city":116,"state":29,"zip":29,"country":117,"countryCode":118,"cosmosGeoPoint":119,"geoPoint":123,"contacts":29},"CHUM","Montreal","Canada","CA",{"type":72,"coordinates":120},[121,122],-73.58781,45.50884,{"lat":122,"lon":121},{"facility":125,"status":29,"city":126,"state":29,"zip":29,"country":127,"countryCode":128,"cosmosGeoPoint":129,"geoPoint":133,"contacts":134},"Landspitali- National University Hospital of Iceland","Reykjavik","Iceland","IS",{"type":72,"coordinates":130},[131,132],-21.89541,64.13548,{"lat":132,"lon":131},[135],{"name":136,"role":62,"phone":29,"phoneExt":29,"email":29},"Johann Ingimarsson",{"type":58,"investigatorFullName":138,"investigatorTitle":139,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"Kymora Scotland, MD, PhD","MD, PhD",[141,142,144,146,147],{"name":78,"class":6},{"name":143,"class":6},"Brigham and Women's Hospital",{"name":145,"class":6},"Landspitali University Hospital",{"name":90,"class":6},{"name":148,"class":6},"Centre hospitalier de l'Université de Montréal (CHUM)","100624318","phase-1-sodium-bicarbonate-as-an-alternative-to-potassium-citrate-for-kidney-stones-100624318",false,"NCT07408076","Sodium Bicarbonate as an Alternative to Potassium Citrate for Kidney Stones","Inclusion Criteria:\n\n* Adult \\>18 years of age\n* History of nephrolithiasis\n* One 24h urine collections within one year of enrollment with hypocitraturia.\n* Patients currently utilizing or considering use of Kcit for stone prevention\n\nExclusion Criteria:\n\n* Individuals with known metabolic disorders\n* Individuals with other known causes of nephrolithiasis\n* Anyone who, in the opinion of the PI, is unfit or unsuitable to participate in the study","ALL","18 Years",{"count":158,"type":159},30,"ESTIMATED","INTERVENTIONAL",[162,163],"PHASE1","PHASE2","Kidney stones affect 1 in every 11 people in the US each year. In patients with kidney stones who are prescribed medications for stone management, only 30.2% are adherent to a medication regime and even fewer, only 13.4 % are adherent with citrate medications.\n\nPrescription potassium citrate can be expensive for many patients, leading to non-compliance. Sodium bicarbonate is a potential medication alternative that is cheaper and can potentially alkalinize the urine and\u002For decrease the risk of future kidney stones. However, efficacy of alternatives to potassium potassium citrate are not well studied.\n\nThis study seeks to evaluate sodium bicarbonate and assess its ability to alkalinize urine in a cohort of patients with kidney stones and compare this to prescription potassium citrate.",[166,167],"Kidney Stones, Urolithiasis, Hypocitraturia","Nephrolithiasis",[169,170,171,172,173,174,175],"kidney stone","stone","calcium oxalate","calcium phosphate","potassium citrate","sodium bicarbonate","nephrolithiasis","NOT_YET_RECRUITING","2026-02-05",{"date":179,"type":180},"2026-02-12","ACTUAL",{"date":182,"type":159},"2026-02-01",{"date":184,"type":159},"2028-02-01",{"name":5,"class":6},6]