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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity of Ilorin Teaching Hospital

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

200 Participants
are divided into 1 treatment group

Sponsors and collaborators

University of Ilorin Teaching Hospital

Lead sponsor

U.S. Army Medical Research and Development Command

Sponsor institution

Mayo Clinic

Collaborator