Immunological Effects of Vitamin D Replacement Among Black/African American Prostate Cancer Patients

StatusRecruiting
PhaseEarly Phase 1
Started

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Trial flagged as At Risk
Primary completion moved at least 2 years later Aug 31, 2026 → Aug 31, 2028
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Record History

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  1. Primary completion pushed from Aug 31, 2026 to Aug 31, 2028
    • Study completion pushed from Aug 31, 2029 to Aug 31, 2031
    • Eligibility criteria expanded, about 15 words
    • Secondary endpoints: details revised at 2 of 3 entries
  2. Re-verified, no change to tracked fieldsv18
  3. Enrollment target: 200 to 220v17
  4. Re-verified, no change to tracked fieldsv16
  5. Collaborators expanded, about 5 wordsv15
Show 13 earlier versionsHide 13 earlier versions
  1. Enrollment target: 400 to 200v14 Show 4 more changesShow less
    • Primary endpoints: 2 to 1
    • Eligibility criteria expanded, about 18 words
    • Secondary endpoints revised (3)
    • Study description expanded, about 21 words
  2. Primary completion date: Aug 31, 2025 to Aug 31, 2026
    • Primary endpoints: 6 to 2
    • Study completion date: Aug 31, 2026 to Aug 31, 2029
    • Secondary endpoints expanded, about 39 words
    v13
  3. Re-verified, no change to tracked fieldsv12
  4. Primary endpoints: 5 to 6
    • Interventions: Cholecalciferol (Dietary Supplement), Quality-of-Life Assessment (Other) to Biospecimen Collection (Procedure), Cholecalciferol (Dietary Supplement), Quality-of-Life Assessment (Other)
    • Eligibility criteria shortened, about 17 words
    • Study description expanded, about 58 words
    v11
  5. Primary endpoints revised (5)
    • Eligibility criteria expanded, about 8 words
    • Study title shortened, about 7 words
    • Study description expanded, about 3 words
    v10
  6. Eligibility criteria expanded, about 25 wordsv9
  7. Primary endpoints revised (5)
    • Eligibility criteria shortened, about 27 words
    • Study description revised
    v8
  8. Primary completion date: Jun 30, 2023 to Aug 31, 2025
    • Start date: Nov 10, 2021 to Dec 29, 2021
    • Study completion date: Jun 30, 2024 to Aug 31, 2026
    v7
  9. Enrollment target: 200 to 400v6 Show 4 more changesShow less
    • Primary endpoints: 13 to 5
    • Eligibility criteria expanded, about 33 words
    • Study sites revised (2)
    • Collaborators shortened, about 4 words
  10. Re-verified, no change to tracked fieldsv5
  11. Study sites: 1 to 2v4
  12. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 30, 2021 to Nov 10, 2021
    • Site details revised
    v3
  13. Start date: Oct 1, 2021 to Dec 30, 2021v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Mayo Clinic
1,024 trials monitored
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Prostate Cancer
2,550 trials monitored
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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.
Trial Details
NCT Number NCT05045066
Lead Sponsor Mayo Clinic
Collaborators: Congressionally Directed Medical Research Programs
Conditions
(from sponsor)		 Localized Prostate Carcinoma, Stage IV Prostate Cancer AJCC v8, Locally Recurrent Prostate Carcinoma, Metastatic Prostate Carcinoma
Related terms Prostatic Neoplasms
Enrollment 220 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov