About this trial
This study is testing whether fixing vitamin D deficiency in Black/West 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.
Key ideas being tested:
1. More than half of Black/West African prostate cancer patients don't have enough vitamin D. 2. Low vitamin D weakens immune cell function and affects quality of life, but these problems improve after 8 weeks of vitamin D supplements. 3. Immune cell function differs between patients with advanced/recurrent prostate cancer and those with localized disease. 4. 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). 5. Immune cell function in Black/West African patients is different from that in Black/African American patients, and this will be checked by comparing data with a parallel Mayo Clinic study.
Overall goals:
1 . Measure how widespread vitamin D deficiency is in Black/West African prostate cancer patients.
2\. 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).
4 . See if vitamin D replacement improves both patient well-being and cancer outcomes.
Study Flow
1\. Recruitment \& Consent: Patients with prostate cancer (localized or advanced) are invited and give written consent.
2 . Initial Blood Test (10 mL): Check vitamin D and calcium levels. 3. Eligibility: If vitamin D is low (\<30 ng/mL), patients join the treatment phase.
4\. Baseline Testing (50 mL blood + QOL survey): Immune function measured; quality of life survey completed; virtual doctor consult.
5\. Treatment (8 weeks): Daily vitamin D3 pills (2000 IU, free); patients keep a medication diary.
6\. 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.
8\. Follow up (up to 3 years). Annual phone calls and medical record review to track progression-free survival.
In short, the study is trying to show that vitamin D deficiency is common in Black/West African prostate cancer patients, that it harms immune function and quality of life, and that correcting it could improve both health and cancer survival.
Eligibility criteria
Qualifiers
Self-identified Black/West African Males, Age ≥18 years
Patients with a previous history of localized or metastatic or locally recurrent prostate cancer
Willing to travel to the University of Ilorin Surgery Outpatient Department (SOPD UITH)for baseline and 8 weeks visit for blood collection, if eligible.
Disqualifiers
Known hypersensitivity to vitamin D.
End-stage renal failure on dialysis
Liver cirrhosis
Currently taking a vitamin D or multivitamin supplement, which has more than 400 IU/10mcg of vitamin D daily for the past month.
Trial design
Treatments tested in this trial
- vitamin D 25(OH)D
Treatment groups
Sponsors and collaborators
University of Ilorin Teaching Hospital
Lead sponsor
U.S. Army Medical Research and Development Command
Sponsor institution
Mayo Clinic
Collaborator