Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2026-01-05 @ 5:29 PM
Study NCT ID:
NCT05045066
Status:
RECRUITING
Last Update Posted:
2025-09-12
First Post:
2021-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunological Effects of Vitamin D Replacement Among Black/African American Prostate Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002762', 'term': 'Cholecalciferol'}, {'id': 'D013048', 'term': 'Specimen Handling'}], 'ancestors': [{'id': 'D002782', 'term': 'Cholestenes'}, {'id': 'D002776', 'term': 'Cholestanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013261', 'term': 'Sterols'}, {'id': 'D014807', 'term': 'Vitamin D'}, {'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-12-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2029-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-05', 'studyFirstSubmitDate': '2021-08-25', 'studyFirstSubmitQcDate': '2021-09-08', 'lastUpdatePostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-09-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in Quality of Life', 'timeFrame': 'Baseline; 8 weeks', 'description': "Assessed by the Human Services' Centers for Disease Control and Prevention (CDC) Health-Related Quality of Life (HRQOL) Healthy Days Questionnaire. The questionnaire consists of 144 questions about an individual's self-rated general health over the past 30 days. Questions ask about the number of days for which mental and physical health was not good (# of days, none, or don't know/not sure) and whether poor mental or physical health days affected usual activities (yes, no, or don't know/not sure). A higher score (more healthy days) reflects better physical and mental well-being, while a lower score (more unhealthy days) indicates a greater impact from poor physical or mental health and activity limitations."}, {'measure': 'Difference in peripheral blood immunological cell function by population', 'timeFrame': 'Up to 3 years', 'description': 'A similar parallel study is being conducted at the University of Ilorin in Ilorin, Nigeria. Immunological results from the study at Mayo Clinic will be compared retrospectively with the results from the study in Nigeria under a separate study protocol.'}], 'primaryOutcomes': [{'measure': 'Change in circulating immunological cell function', 'timeFrame': 'Baseline; 8 weeks', 'description': 'Participants will have blood drawn to measure serum levels of 25-hydroxyvitamin D (25OHD) and to determine immune response. Laboratory endpoints for the levels of antigen-specific T cells and antibodies before and after vitamin D supplementation will be compared. A participant will be considered to have responded if they have developed a ≥3-fold increase in antigen-specific T cells or antibodies at 8 weeks. If T-cell immunity is undetectable, a positive response will be defined as ≥50 antigen-specific T cells/million PBMCs.'}], 'secondaryOutcomes': [{'measure': 'Prevalence of vitamin D insufficiency', 'timeFrame': 'Baseline; 8 weeks', 'description': 'Participants will have blood drawn to measure serum levels of 25OHD. The mean and median 25OHD level will be estimated, as well as the percentage of participants that have low vitamin D levels (\\<30 ng/mL).'}, {'measure': 'Differences in the peripheral blood immunological cell function', 'timeFrame': 'Baseline; 8 weeks', 'description': 'Levels of antigen-specific T cells and antibodies before and after vitamin D supplementation will be compared between black/AA patients with metastatic or locally recurrent prostate cancer and those with localized prostate cancer'}, {'measure': 'Vitamin D replacement association with PSA progression free survival (PSA-PFS)', 'timeFrame': 'Up to 3 years', 'description': 'Participants with detectable changes in immune response will be compared to those with no detectable changes in immune response and compared to stage-matched historical controls to determine whether vitamin D replacement is associated with improvement in PFA-PFS.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Localized Prostate Carcinoma', 'Stage IV Prostate Cancer AJCC v8', 'Locally Recurrent Prostate Carcinoma', 'Metastatic Prostate Carcinoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. Determine the changes in circulating immunological cell function among patients with vitamin D insufficiency and the effects of vitamin D replacement on those changes.\n\nSECONDARY OBJECTIVES:\n\nI. Determine the prevalence of vitamin D insufficiency among black / African American (AA) prostate cancer patients.\n\nII. Determine if there are differences in the peripheral blood immunological cell function in black/AA patients with metastatic or locally recurrent prostate cancer compared to those with localized prostate cancer.\n\nIII. Determine if vitamin D replacement is associated with improvement in prostate-specific antigen (PSA) progression free survival (PSA-PFS) of black/AA patients with prostate cancer with detectable changes in immune response compared to those with no detectable changes in immune response and compared to stage matched historical controls.\n\nCORRELATIVE OBJECTIVE:\n\nI. Determine if there are differences in the peripheral blood immunological cell function in Black/AA patients compared to West African/Black patients from Nigeria.\n\nOUTLINE:\n\nPatients with low vitamin D3 levels receive cholecalciferol orally (PO) daily for 8 weeks in the absence of unacceptable toxicity. Patients undergo blood sample collection throughout the study.\n\nAfter completion of study treatment, patients are followed up at 56 days and then annually for 3 years.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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/ml\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/10mcg 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'}, 'identificationModule': {'nctId': 'NCT05045066', 'briefTitle': 'Immunological Effects of Vitamin D Replacement Among Black/African American Prostate Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Differences in Immunological Effects of Vitamin D Replacement Among Black/African American (AA) Prostate Cancer Patients With Localized Versus Metastatic Disease', 'orgStudyIdInfo': {'id': 'MC210501'}, 'secondaryIdInfos': [{'id': 'HT94252411104', 'type': 'OTHER_GRANT', 'domain': 'Department of Defense'}, {'id': 'PC230672P11', 'type': 'OTHER_GRANT', 'domain': 'Department of Defense'}, {'id': 'NCI-2021-08987', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '21-004555', 'type': 'OTHER', 'domain': 'Mayo Clinic Institutional Review Board'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment (cholecalciferol)', 'description': '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.', 'interventionNames': ['Dietary Supplement: Cholecalciferol', 'Other: Quality-of-Life Assessment', 'Procedure: Biospecimen Collection']}], 'interventions': [{'name': 'Cholecalciferol', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['9,10-Secocholesta-5,7,10(19)-trien-3-ol', 'Calciol', 'Delsterol', 'Vitamin D3'], 'description': 'Given PO', 'armGroupLabels': ['Treatment (cholecalciferol)']}, {'name': 'Quality-of-Life Assessment', 'type': 'OTHER', 'otherNames': ['Quality of Life Assessment'], 'description': 'Ancillary studies', 'armGroupLabels': ['Treatment (cholecalciferol)']}, {'name': 'Biospecimen Collection', 'type': 'PROCEDURE', 'otherNames': ['Biological Sample Collection', 'Biospecimen Collected', 'Specimen Collection'], 'description': 'Undergo blood sample collection', 'armGroupLabels': ['Treatment (cholecalciferol)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Clinical Trials Referral Office', 'role': 'CONTACT', 'email': 'mayocliniccancerstudies@mayo.edu', 'phone': '855-776-0015'}, {'name': 'Cassandra N. Moore, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mayo Clinic in Arizona', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '32224-9980', 'city': 'Jacksonville', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Clinical Trials Referral Office', 'role': 'CONTACT', 'email': 'mayocliniccancerstudies@mayo.edu', 'phone': '855-776-0015'}, {'name': 'Gerardo Colon-Otero, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mayo Clinic in Florida', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}], 'centralContacts': [{'name': 'Clinical Trials Referral Office', 'role': 'CONTACT', 'email': 'mayocliniccancerstudies@mayo.edu', 'phone': '855-776-0015'}, {'name': 'Cancer Center Clinical Trials', 'role': 'CONTACT', 'phone': '866-273-4681 or 507-266-4000'}], 'overallOfficials': [{'name': 'Gerardo Colon-Otero, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}