Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer (Adenocarcinoma) | Malignant Prostate Neoplasm | CURATED_EXACT | 0.85 |
| Vitamin D on Tumor Response and Inflammatory Markers | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| vitamin D 25(OH)D | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Vitamin Deficiency patients who will have Vitamin D Supplements
- description
- 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
- interventionNames
- Drug: vitamin D 25(OH)D
Primary outcomes (2)
- measure
- Proportion of Men with Advanced Prostate Cancer with Vitamin D Deficiency
- timeFrame
- 48 months
- description
- 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.
- measure
- Serum levels of Vitamin D in African Men with Advanced Prostate Cancer .
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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
References
Publications (10)
- BACKGROUNDNelson 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
- BACKGROUNDSong 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
- BACKGROUNDAndersen 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
- BACKGROUNDGrant 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
- BACKGROUNDKanno 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
- BACKGROUNDZhang 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
- BACKGROUNDAranow C. Vitamin D and the immune system. J Investig Med. 2011 Aug;59(6):881-6. doi: 10.2310/JIM.0b013e31821b8755. PMID 21527855