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.

Timeline

Start

2026-06-01

Primary completion

2028-06-01

Completion

2028-09-01

Publications

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

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