[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638317":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":30,"locations":41,"responsibleParty":67,"collaborators":71,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":20,"enrollmentInfo":83,"targetDuration":20,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":93,"overallStatus":97,"whyStopped":20,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"University of Ilorin Teaching Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Vitamin Deficiency patients who will have Vitamin D Supplements","EXPERIMENTAL","2000 IU of Vitamin D supplement will be given to the patients with advanced prostate cancer who have Vitamin D levels less than 30 ng\u002F ml for 8 weeks",[13],"Drug: vitamin D 25(OH)D",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","vitamin D 25(OH)D","2000 IU of vitamin D will be given to the patients with prostate cancer with Serum low Vitamin D levels ( he Locally advanced Group and the group with metastasis).",[9],null,[22,26],{"name":23,"affiliation":24,"role":25},"Ademola A Popoola, MBBS,MD, FWACS, FMCS","Department of Surgery, University of Ilorin Teaching Hospital \u002F University of Ilorin","PRINCIPAL_INVESTIGATOR",{"name":27,"affiliation":28,"role":29},"Remi S Solagbade, MBBS","Department of Surgery , University of Ilorin Teaching Hospital","STUDY_DIRECTOR",[31,37],{"name":32,"role":33,"phone":34,"phoneExt":35,"email":36},"Ademola A Popoola, MD","CONTACT","+2348032224299","000","ademolapopoola@unilorin.edu.ng",{"name":38,"role":33,"phone":39,"phoneExt":35,"email":40},"Remi S Solagbade, MD","+2347037779545","solagbaders@gmail.com",[42],{"facility":5,"status":20,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Ilorin","Kwara State","240001","Nigeria","NG",{"type":49,"coordinates":50},"Point",[51,52],4.54214,8.49664,{"lat":52,"lon":51},[55,56,60,63,65],{"name":38,"role":33,"phone":39,"phoneExt":35,"email":40},{"name":57,"role":33,"phone":58,"phoneExt":35,"email":59},"Abiodun L Azeez, MD","+2347065870498","azeezlateefabiodun@yahoo.com",{"name":61,"role":62,"phone":20,"phoneExt":20,"email":20},"Hannah O Olawumi, MD","SUB_INVESTIGATOR",{"name":64,"role":62,"phone":20,"phoneExt":20,"email":20},"Ismail Oseni, MD",{"name":66,"role":62,"phone":20,"phoneExt":20,"email":20},"Joshua Abiodun, PhD",{"type":25,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":70,"oldNameTitle":20,"oldOrganization":20},"Ademola A Popoola","Urologist \u002F Oncologist \u002F University Lecturer","U.S. Army Medical Research and Development Command",[72],{"name":73,"class":6},"Mayo Clinic","100638317","phase-3-comparative-analysis-of-immunological-responses-to-vitamin-d-replacement-therapy-in-black-and-west-african-men-diagnosed-with-prostate-cancer-elucidating-differential-effects-on-immune-function-between-patients-with-localized-disease-and-those-with-metastatic-progression-100638317",false,"NCT07598032","Comparative Analysis of Immunological Responses to Vitamin D Replacement Therapy in Black and West African Men Diagnosed With Prostate Cancer: Elucidating Differential Effects on Immune Function Between Patients With Localized Disease and Those With Metastatic Progression","iCCaRE","Inclusion Criteria:\n\n* Self-identified Black\u002FWest African Males, Age ≥18 years\n* Patients with a previous history of localized or metastatic or locally recurrent prostate cancer\n* Willing to travel to the University of Ilorin Surgery Outpatient Department (SOPD UITH)for baseline and 8 weeks visit for blood collection, if eligible.\n\nExclusion Criteria:\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, which 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* History of hypercalcemia","MALE","18 Years",{"count":84,"type":85},200,"ESTIMATED","INTERVENTIONAL",[88],"PHASE3","This study is testing whether fixing vitamin D deficiency in Black\u002FWest African men with prostate cancer can strengthen their immune system, improve quality of life, and even slow cancer progression compared to those who remain deficient.\n\nKey ideas being tested:\n\n1. More than half of Black\u002FWest African prostate cancer patients don't have enough vitamin D.\n2. Low vitamin D weakens immune cell function and affects quality of life, but these problems improve after 8 weeks of vitamin D supplements.\n3. Immune cell function differs between patients with advanced\u002Frecurrent prostate cancer and those with localized disease.\n4. Patients with advanced disease who show stronger immune responses after vitamin D correction may live longer without their PSA levels rising (a marker of cancer progression).\n5. Immune cell function in Black\u002FWest African patients is different from that in Black\u002FAfrican American patients, and this will be checked by comparing data with a parallel Mayo Clinic study.\n\nOverall goals:\n\n1 . Measure how widespread vitamin D deficiency is in Black\u002FWest African prostate cancer patients.\n\n2\\. Understand how vitamin D levels affect immunity and quality of life. 3. Compare immune function between different groups (localized vs. advanced disease, West African vs. African American patients).\n\n4 . See if vitamin D replacement improves both patient well-being and cancer outcomes.\n\nStudy Flow\n\n1\\. Recruitment \\& Consent: Patients with prostate cancer (localized or advanced) are invited and give written consent.\n\n2 . Initial Blood Test (10 mL): Check vitamin D and calcium levels. 3. Eligibility: If vitamin D is low (\\\u003C30 ng\u002FmL), patients join the treatment phase.\n\n4\\. Baseline Testing (50 mL blood + QOL survey): Immune function measured; quality of life survey completed; virtual doctor consult.\n\n5\\. Treatment (8 weeks): Daily vitamin D3 pills (2000 IU, free); patients keep a medication diary.\n\n6\\. Midpoint Check (Week 4): Phone call to check side effects and compliance. 7 .End of Treatment (Week 8): Repeat blood tests (60 mL), second QOL survey, virtual consult.\n\n8\\. Follow up (up to 3 years). Annual phone calls and medical record review to track progression-free survival.\n\nIn short, the study is trying to show that vitamin D deficiency is common in Black\u002FWest African prostate cancer patients, that it harms immune function and quality of life, and that correcting it could improve both health and cancer survival.",[91,92],"Prostate Cancer (Adenocarcinoma)","Vitamin D on Tumor Response and Inflammatory Markers",[94,95,96],"Advanced Prostate Cancer","Vitamin D deficency","immunity","NOT_YET_RECRUITING","2026-05-17",{"date":100,"type":101},"2026-05-20","ACTUAL",{"date":103,"type":85},"2026-06-01",{"date":105,"type":85},"2028-09-01",{"name":5,"class":6},1]