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

Summary

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.

Conditions

• Prostate Cancer (Adenocarcinoma)
• Vitamin D on Tumor Response and Inflammatory Markers

Interventions

DRUG

vitamin D 25(OH)D

2000 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).

Sponsors & Collaborators

• Mayo Clinic

  collaborator OTHER

• University of Ilorin Teaching Hospital

  lead OTHER

Principal Investigators

• Ademola A Popoola, MBBS,MD, FWACS, FMCS · Department of Surgery, University of Ilorin Teaching Hospital / University of Ilorin

• Remi S Solagbade, MBBS · Department of Surgery , University of Ilorin Teaching Hospital

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-06-01

Primary Completion

2028-06-01

Completion

2028-09-01

Countries

• Nigeria

Study Locations