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

NCT07598032 | Not Yet Recruiting Phase 3 DMC

• 2 other identifiers: UIlorinTeachingHUNI-351872
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. 1.More than half of Black/West African prostate cancer patients don't have enough vitamin D.
2. 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. 3.Immune cell function differs between patients with advanced/recurrent prostate cancer and those with localized disease.
4. 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. 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.

Conditions

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

Keywords

Advanced Prostate Cancer; Vitamin D deficency; immunity

Outcome Measures

Primary Outcomes (2)

• 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.

  48 months

• 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).

  The test will be done at the time of recruitment and at 8 weeks after the supplementation

Secondary Outcomes (3)

• Tolerability of eight weeks of Vitamin D supplementation in African men with Advanced Prostate Cancer who have low levels of Vitamin D

  Tolerability will be monitored during the 8-week supplementation period and for an additional 8 weeks thereafter, covering a total duration of 16 weeks.

• Vitamin D supplementation and PSA levels in advanced prostate cancer.

  The PSA will be measured every three months for each patient 36 months

• Vitamin D supplementation and immune cell activity in advanced prostate cancer.

  The immune cell counts will be measured at the recruitment after 8 weeks

Study Arms (1)

Vitamin Deficiency patients who will have Vitamin D Supplements

EXPERIMENTAL

2000 IU of Vitamin D supplement will be given to the patients with advanced prostate cancer who have Vitamin D levels less than 30 ng/ ml for 8 weeks

Drug: vitamin D 25(OH)D

Interventions

vitamin D 25(OH)D DRUG

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).

Vitamin Deficiency patients who will have Vitamin D Supplements

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Legal inability or restricted legal ability, medical or psychological conditions not allowing proper study completion or informed consent signature.
• History of hypercalcemia

Sponsors & Collaborators

• Mayo Clinic: collaborator
• University of Ilorin Teaching Hospital: lead

Study Sites (1)

University of Ilorin Teaching Hospital

Ilorin, Kwara State, 240001, Nigeria

Location

Related Publications (10)

• Nelson SM, Batai K, Ahaghotu C, Agurs-Collins T, Kittles RA. Association between Serum 25-Hydroxy-Vitamin D and Aggressive Prostate Cancer in African American Men. Nutrients. 2016 Dec 28;9(1):12. doi: 10.3390/nu9010012.

  PMID: 28036013 BACKGROUND

• Song ZY, Yao Q, Zhuo Z, Ma Z, Chen G. Circulating vitamin D level and mortality in prostate cancer patients: a dose-response meta-analysis. Endocr Connect. 2018 Dec 1;7(12):R294-R303. doi: 10.1530/EC-18-0283.

  PMID: 30352424 BACKGROUND

• Andersen MR, Sweet E, Hager S, Gaul M, Dowd F, Standish LJ. Effects of Vitamin D Use on Health-Related Quality of Life of Breast Cancer Patients in Early Survivorship. Integr Cancer Ther. 2019 Jan-Dec;18:1534735418822056. doi: 10.1177/1534735418822056. Epub 2019 Jan 7.

  PMID: 30616390 BACKGROUND

• Grant WB, Peiris AN. Differences in vitamin D status may account for unexplained disparities in cancer survival rates between African and white Americans. Dermatoendocrinol. 2012 Apr 1;4(2):85-94. doi: 10.4161/derm.19667.

  PMID: 22928063 BACKGROUND

• Kanno K, Akutsu T, Ohdaira H, Suzuki Y, Urashima M. Effect of Vitamin D Supplements on Relapse or Death in a p53-Immunoreactive Subgroup With Digestive Tract Cancer: Post Hoc Analysis of the AMATERASU Randomized Clinical Trial. JAMA Netw Open. 2023 Aug 1;6(8):e2328886. doi: 10.1001/jamanetworkopen.2023.28886.

  PMID: 37606927 BACKGROUND

• Zhang Y, Fang F, Tang J, Jia L, Feng Y, Xu P, Faramand A. Association between vitamin D supplementation and mortality: systematic review and meta-analysis. BMJ. 2019 Aug 12;366:l4673. doi: 10.1136/bmj.l4673.

  PMID: 31405892 BACKGROUND

• Aranow C. Vitamin D and the immune system. J Investig Med. 2011 Aug;59(6):881-6. doi: 10.2310/JIM.0b013e31821b8755.

  PMID: 21527855 BACKGROUND

• Peng X, Vaishnav A, Murillo G, Alimirah F, Torres KE, Mehta RG. Protection against cellular stress by 25-hydroxyvitamin D3 in breast epithelial cells. J Cell Biochem. 2010 Aug 15;110(6):1324-33. doi: 10.1002/jcb.22646.

  PMID: 20564226 BACKGROUND

• Hoogendijk WJ, Lips P, Dik MG, Deeg DJ, Beekman AT, Penninx BW. Depression is associated with decreased 25-hydroxyvitamin D and increased parathyroid hormone levels in older adults. Arch Gen Psychiatry. 2008 May;65(5):508-12. doi: 10.1001/archpsyc.65.5.508.

  PMID: 18458202 BACKGROUND

• Stechschulte SA, Kirsner RS, Federman DG. Vitamin D: bone and beyond, rationale and recommendations for supplementation. Am J Med. 2009 Sep;122(9):793-802. doi: 10.1016/j.amjmed.2009.02.029.

  PMID: 19699370 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms; Adenocarcinoma

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Ademola A Popoola, MBBS,MD, FWACS, FMCS

  Department of Surgery, University of Ilorin Teaching Hospital / University of Ilorin

  PRINCIPAL INVESTIGATOR

• Remi S Solagbade, MBBS

  Department of Surgery , University of Ilorin Teaching Hospital

  STUDY DIRECTOR

Central Study Contacts

Ademola A Popoola, MD

CONTACT

+2348032224299; ademolapopoola@unilorin.edu.ng

Remi S Solagbade, MD

CONTACT

+2347037779545; solagbaders@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Urologist / Oncologist / University Lecturer

Model Details: Background and Rationale Advanced prostate cancer patients often present with compromised immunity and poor nutritional status. Vitamin D deficiency is common in this population and has been linked to impaired immune function, increased inflammation, and worse cancer outcomes. Supplementation may improve immune markers, reduce systemic inflammation, and enhance quality of life. Study Objectives Primary Objective: To evaluate the effect of 8 weeks of vitamin D supplementation on immune function in patients with advanced prostate cancer and vitamin D deficiency. Secondary Objectives: Assess changes in serum vitamin D levels. Monitor inflammatory biomarkers (e.g., CRP, IL-6, TNF-α). Evaluate patient-reported outcomes such as fatigue and quality of life. Explore potential effects on disease progression markers. Study Design Type: Longitudinal, Uncontrolled intervention study. Duration: 8 weeks. Population: Inclusion: Male patients ≥18 years, diagnosed with advanced prostate cancer

Study Record Dates

• First Submitted: February 16, 2026
• First Posted: May 20, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: September 2027 for three years
• Access Criteria: The PI of the parrallel clinical trial taking place in Mayo Clinic, Jacksonville, Dr. Colon-Otero and those that he delegates will be able to access through RedCap

Locations

NG (1)