[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100471337":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":33,"locations":38,"responsibleParty":55,"collaborators":57,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":67,"acronym":25,"eligibilityCriteria":68,"healthyVolunteers":69,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":25,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":40,"whyStopped":25,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"University of Alabama at Birmingham","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Healthy Participants","EXPERIMENTAL","Healthy participants will randomly receive either high (250mg) or low (40mg) oxalate diet for for four days, a ten day \"washout\" period on a self-selected diet, and finally the opposite diet from the first for the last four days.",[13,14],"Dietary Supplement: Low Oxalate Diet","Dietary Supplement: High Oxalate Diet",{"label":16,"type":10,"description":17,"interventionNames":18},"Calcium Oxalate Kidney Stone","Calcium oxalate kidney stone participants will randomly receive either high (250mg) or low (40mg) oxalate diet for for four days, a ten day \"washout\" period on a self-selected diet, and finally the opposite diet from the first for the last four days.",[13,14],[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DIETARY_SUPPLEMENT","Low Oxalate Diet","Participants will consume a diet that is controlled in its daily contents of oxalate and calcium, and in its content of carbohydrate, fat, and protein. Participants will be asked not to take any dietary supplements, exercise strenuously, or consume food or drink that is not provided to them.",[16,9],null,{"type":21,"name":27,"description":23,"armGroupLabels":28,"otherNames":25},"High Oxalate Diet",[16,9],[30],{"name":31,"affiliation":5,"role":32},"Tanecia Mitchell, PhD","PRINCIPAL_INVESTIGATOR",[34],{"name":31,"role":35,"phone":36,"phoneExt":25,"email":37},"CONTACT","(205) 996-2292","taneciamitchell@uabmc.edu",[39],{"facility":5,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"RECRUITING","Birmingham","Alabama","35294","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-86.80249,33.52066,{"lat":50,"lon":49},[53,54],{"name":31,"role":35,"phone":36,"phoneExt":25,"email":37},{"name":31,"role":32,"phone":25,"phoneExt":25,"email":25},{"type":32,"investigatorFullName":31,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Principal Investigator",[58,61],{"name":59,"class":60},"National Institutes of Health (NIH)","NIH",{"name":62,"class":60},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","100471337","oxalate-driven-host-responses-in-kidney-stone-disease-100471337",false,"NCT05417568","Oxalate-Driven Host Responses in Kidney Stone Disease","Inclusion Criteria:\n\n* Men and women between the ages of 18 and 60 years old.\n* Able to provide informed consent.\n* BMI between 20-30 kg\u002Fm2.\n* Non-tobacco users or not pregnant\u002Fbreastfeeding\u002Fnursing.\n* Normal fasting blood comprehensive metabolic panel, complete blood count, C-reactive protein, and urinalysis. Must accurately collect two 24-hour urine collections within 20% of the appropriate ratio of creatinine (mg)\u002Fbody weight (kg) for respective gender.\n* Healthy subjects: No history of CaOx KS or other medical conditions.\n* Patients with CaOx KS: Recent stone composition \\> 50% CaOx; no uric acid, struvite, or carbonate apatite stone content. Must be first-time or recurrent CaOx stone former (last stone event ≤ 3 years).\n* Willing to not consume supplements (i.e. vitamins, Ca (citrate or carbonate) and other minerals, herbal supplements, nutritional aids, and probiotics) for 2 weeks before the study and during the study.\n* Willing to abstain from vigorous exercise during the study as this may compromise immune function.\n* Willing to consume diets provided only by the UAB CCTS Bionutrition Core. No food allergies or intolerance to any of the foods on the study menus.\n* Willing to accurately collect 24-hour urine samples, and to have blood drawn throughout the study.\n* If on medications for KS prevention (e.g. thiazides, citrate supplementation excluding calcium citrate), patients must be on a stable dose regimen for at least 8 weeks prior to and during screening, with no changes in dosing anticipated during the study. Patients should not take allopurinol for 2 weeks prior to screening since allopurinol has antioxidant properties.\n\nExclusion Criteria:\n\n* Failure to meet the inclusion criteria or physician refusal.\n* Inability to sign and read the informed consent.\n* Any medical, psychiatric, or social conditions that would prohibit participants from abiding by the study requirements.\n* BMI ˃30 kg\u002Fm2 and \\\u003C20 kg\u002Fm2\n* Tobacco users or pregnant or breastfeeding\u002Fnursing women.\n* Abnormal fasting blood comprehensive metabolic panel, complete blood count, C-reactive protein, and urinalysis. Inaccurate 24-hour urine collections.\n* Healthy subjects: Currently taking or have recently taken medications within the last 3 months (i.e. antibiotics) or dietary supplements. History of KS or any medical condition that could influence absorption or excretion of oxalate.\n* Active illness including COVID-19, flu, common cold, fever, diarrhea, urinary tract infections, or other infections 14 days before the study and throughout the study.",true,"ALL","18 Years","60 Years",{"count":74,"type":75},88,"ESTIMATED","INTERVENTIONAL",[78],"NA","This study is looking to understand the role of oxalate on kidney stone development and immunity. This study will enroll healthy participants and participants with calcium oxalate kidney stones (CaOx KS). Participants will be in this study for about 3 weeks, consume controlled diets, and provide blood and urine specimens.",[81],"Kidney Stones",[83,84],"Kidney stones","Dietary oxalate","2026-05-12",{"date":87,"type":88},"2026-05-15","ACTUAL",{"date":90,"type":88},"2023-05-19",{"date":92,"type":75},"2027-05-30",{"name":5,"class":6},1]