[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100442721":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":42,"centralContacts":46,"locations":56,"responsibleParty":88,"collaborators":90,"id":94,"slug":95,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":51,"eligibilityCriteria":100,"healthyVolunteers":96,"sex":101,"minAge":102,"maxAge":51,"enrollmentInfo":103,"targetDuration":51,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":51,"overallStatus":59,"whyStopped":51,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"Mayo Clinic","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment (cholecalciferol)","EXPERIMENTAL","Patients with low vitamin D3 levels receive cholecalciferol PO daily for 8 weeks in the absence of unacceptable toxicity. Patients undergo blood sample collection throughout the study.",[13,14,15],"Dietary Supplement: Cholecalciferol","Other: Quality-of-Life Assessment","Procedure: Biospecimen Collection",[17,27,33],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"DIETARY_SUPPLEMENT","Cholecalciferol","Given PO",[9],[23,24,25,26],"9,10-Secocholesta-5,7,10(19)-trien-3-ol","Calciol","Delsterol","Vitamin D3",{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Quality-of-Life Assessment","Ancillary studies",[9],[32],"Quality of Life Assessment",{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"PROCEDURE","Biospecimen Collection","Undergo blood sample collection",[9],[39,40,41],"Biological Sample Collection","Biospecimen Collected","Specimen Collection",[43],{"name":44,"affiliation":5,"role":45},"Gerardo Colon-Otero, M.D.","PRINCIPAL_INVESTIGATOR",[47,53],{"name":48,"role":49,"phone":50,"phoneExt":51,"email":52},"Clinical Trials Referral Office","CONTACT","855-776-0015",null,"mayocliniccancerstudies@mayo.edu",{"name":54,"role":49,"phone":55,"phoneExt":51,"email":51},"Cancer Center Clinical Trials","866-273-4681 or 507-266-4000",[57,75],{"facility":58,"status":59,"city":60,"state":61,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"Mayo Clinic in Arizona","RECRUITING","Scottsdale","Arizona","85259","United States","US",{"type":66,"coordinates":67},"Point",[68,69],-111.89903,33.50921,{"lat":69,"lon":68},[72,73],{"name":48,"role":49,"phone":50,"phoneExt":51,"email":52},{"name":74,"role":45,"phone":51,"phoneExt":51,"email":51},"Cassandra N. Moore, M.D.",{"facility":76,"status":59,"city":77,"state":78,"zip":79,"country":63,"countryCode":64,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"Mayo Clinic in Florida","Jacksonville","Florida","32224-9980",{"type":66,"coordinates":81},[82,83],-81.65565,30.33218,{"lat":83,"lon":82},[86,87],{"name":48,"role":49,"phone":50,"phoneExt":51,"email":52},{"name":44,"role":45,"phone":51,"phoneExt":51,"email":51},{"type":89,"investigatorFullName":51,"investigatorTitle":51,"investigatorAffiliation":51,"oldNameTitle":51,"oldOrganization":51},"SPONSOR",[91],{"name":92,"class":93},"Congressionally Directed Medical Research Programs","FED","100442721","early-phase-1-immunological-effects-of-vitamin-d-replacement-among-blackafrican-american-prostate-cancer-patients-100442721",false,"NCT05045066","Immunological Effects of Vitamin D Replacement Among Black\u002FAfrican American Prostate Cancer Patients","MC210501 Differences in Immunological Effects of Vitamin D Replacement Among Black\u002F African American (AA) Prostate Cancer Patients With Localized Versus Metastatic Disease","Inclusion Criteria:\n\n* Pre-Registration:\n\n  * African American males, age \\>= 18 years\n  * Patients with a previous history of localized or metastatic or locally recurrent prostate cancer\n* Registration:\n\n  * Patients with Vitamin D levels below 30 ng\u002Fml\n\nExclusion Criteria:\n\n* Pre-Registration:\n\n  * Known hypersensitivity to vitamin D\n  * End stage renal failure on dialysis\n  * Liver cirrhosis\n  * Currently taking a vitamin D or multivitamin supplement, that has more than 400 IU\u002F10mcg of vitamin D daily for the past month\n  * Legal inability or restricted legal ability, medical or psychological conditions not allowing proper study completion or informed consent signature\n  * Chemotherapy or surgery or radiation within the last 3 weeks prior to blood collection\n  * History of hypercalcemia\n* Registration:\n\n  * Chemotherapy or surgery or radiation within the last 3 weeks prior to blood collection","MALE","18 Years",{"count":104,"type":105},220,"ESTIMATED","INTERVENTIONAL",[108],"EARLY_PHASE1","This early phase I is to find out how common vitamin D insufficiency is among African American patients with a history of prostate cancer that has not spread to other parts of the body (localized) or has spread to other places in the body (metastatic) and how vitamin D insufficiency affects the immune system. This study also aims to find out if replacing vitamin D results in normalization of the immune function. Information from this study may benefit prostate cancer patients by identifying vitamin D insufficiency which in several studies had been found to contribute to more aggressive prostate cancers.",[111,112,113,114],"Localized Prostate Carcinoma","Stage IV Prostate Cancer AJCC v8","Locally Recurrent Prostate Carcinoma","Metastatic Prostate Carcinoma","2026-06-04",{"date":117,"type":118},"2026-06-08","ACTUAL",{"date":120,"type":118},"2021-12-29",{"date":122,"type":105},"2029-08-31",{"name":5,"class":6},2]