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
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Proportion of Men with Advanced Prostate Cancer with Vitamin D Deficiency
研究概览
简要总结
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:
- More than half of Black/West African prostate cancer patients don't have enough vitamin D.
- Low vitamin D weakens immune cell function and affects quality of life, but these problems improve after 8 weeks of vitamin D supplements.
- Immune cell function differs between patients with advanced/recurrent prostate cancer and those with localized disease.
- 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).
- 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.
详细描述
Principal Investigators:
University of Ilorin, Ilorin, Nigeria: Ademola Alabi Popoola, MBBCH; Joshua Abiodun, PhD; Collaborators: Mayo Clinic, Jacksonville, Florida, USA: Gerardo Colon-Otero, MD, Trevanne Matthews-Hew, MD, Kim Barbel-Johnson, MD, Sandra Casanova, Keith L. Knutson,n PhD, For research laboratory tests that will be performed at the Mayo Clinic and planned retrospective comparisons with a parallel Mayo Clinic.
This clinical trial, designed to explore the potential role of vitamin D supplementation in improving outcomes among West African men with advanced prostate cancer, is grounded in the following hypothesis.
Clinical Trial Hypotheses Prevalence of Vitamin D Insufficiency More than half of Black/West African prostate cancer patients are expected to have vitamin D insufficiency.
Impact on Immune Function & Quality of Life Vitamin D insufficiency is associated with altered immune cell function and reduced health-related quality of life. Both are expected to improve after 8 weeks of vitamin D replacement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Vitamin Deficiency patients who will have Vitamin D Supplements
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
干预措施: vitamin D 25(OH)D (Drug)
结局指标
主要结局
Proportion of Men with Advanced Prostate Cancer with Vitamin D Deficiency
时间窗: 48 months
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.
Serum levels of Vitamin D in African Men with Advanced Prostate Cancer .
时间窗: The test will be done at the time of recruitment and at 8 weeks after the supplementation
The serum 25(OH)D levels will be measured using Enzyme Linked Immunosorbent Assay (ELISA) (target: 30-50 ng/mL).
次要结局
- 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)
研究者
Ademola A Popoola
Urologist / Oncologist / University Lecturer
U.S. Army Medical Research and Development Command