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.
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.
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.
Single group
vitamin D 25(OH)D
Drug2000 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).
Proportion of Men with Advanced Prostate Cancer with Vitamin D Deficiency
The proportion of African men with advanced prostate cancer who have low vitamin D levels will be calculated as the number of men with vitamin D deficiency divided by the total number of men diagnosed with advanced prostate cancer.
Serum levels of Vitamin D in African Men with Advanced Prostate Cancer .
The serum 25(OH)D levels will be measured using Enzyme Linked Immunosorbent Assay (ELISA) (target: 30-50 ng/mL).
Tolerability of eight weeks of Vitamin D supplementation in African men with Advanced Prostate Cancer who have low levels of Vitamin D
The participants' tolerance of vitamin D supplementation will be measured by the following: Symptoms of vitamin D intolerance will be documented by looking at the proportion of men with the following symptoms. These include the following: Gastrointestinal (nausea, vomiting, constipation, abdominal pain, and loss of appetite); Neuromuscular (weakness, fatigue, muscle aches, and confusion); bone pain; dehydration; and blood pressure changes.
Vitamin D supplementation and PSA levels in advanced prostate cancer.
This study aims to evaluate whether vitamin D supplementation in patients with advanced prostate cancer alters serum prostate-specific antigen (PSA) levels, a validated surrogate marker of disease progression. PSA concentrations are reported in nanograms per milliliter (ng/mL).
Vitamin D supplementation and immune cell activity in advanced prostate cancer.
This trial investigates whether vitamin D supplementation influences immune activity. Immune cell counts are reported in cells per microliter (cells/µL).
Click on the lead sponsor to view all of their trials.
University of Ilorin Teaching Hospital
Lead sponsor
U.S. Army Medical Research and Development Command
Sponsor institution
Mayo Clinic
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
