A Phase 3 interventional study of vitamin D 25(OH)D in Prostate Cancer (Adenocarcinoma) and Vitamin D on Tumor Response and Inflammatory Markers, sponsored by University of Ilorin Teaching Hospital. Not yet recruiting at 1 site in Nigeria. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-20.
Sponsored by University of Ilorin Teaching Hospital · Phase 3, Interventional, and Treatment
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:
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.
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.
Disease Stage Differences Immune cell function differs significantly between patients with metastatic/locally recurrent prostate cancer and those with localized disease.
PSA Progression-Free Survival Patients with metastatic or recurrent disease who show an improved immune response after vitamin D correction will have better PSA progression-free survival than those without immune response changes.
Comparisons Across Populations Immune cell function in Black/West African prostate cancer patients differs from that in Black/African American patients. This will be tested by comparing data from this study with a parallel Mayo Clinic study, both partially funded by the U.S. Department of Defense.
Study Aims \& Purpose
Specific Objectives
Background Context
Preliminary Data
Study Design \& Methods
Pre-screening: Serum vitamin D and calcium testing. Patients with vitamin D \<30 ng/ml will be enrolled in the therapeutic arm. Intervention: Oral vitamin D3 (2000 IU daily, free of charge) for 8 weeks. Monitoring: Medication diary, 4-week phone check, baseline, and 8-week blood draws for immune function tests.
Quality of life: CDC HRQOL-4 survey at baseline and 8 weeks. Follow-up: Annual contact up to 3 years for PSA progression-free survival (PSA-PFS).
Study Aims (Detailed)
Target Accrual
Subject Population
Specimen Handling
Data Analysis Plan
Endpoints
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's planned enrollment of 200 is above the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →This is the only study on the registry with University of Ilorin Teaching Hospital as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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).
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.
Time frame: 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).
Time frame: The test will be done at the time of recruitment and at 8 weeks after the supplementation
Tolerability of eight weeks of Vitamin D supplementation in African men with Advanced Prostate Cancer who have low levels of Vitamin D
The participants' tolerance of vitamin D supplementation will be measured by the following: Symptoms of vitamin D intolerance will be documented by looking at the proportion of men with the following symptoms. These include the following: Gastrointestinal (nausea, vomiting, constipation, abdominal pain, and loss of appetite); Neuromuscular (weakness, fatigue, muscle aches, and confusion); bone pain; dehydration; and blood pressure changes.
Time frame: 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.
This study aims to evaluate whether vitamin D supplementation in patients with advanced prostate cancer alters serum prostate-specific antigen (PSA) levels, a validated surrogate marker of disease progression. PSA concentrations are reported in nanograms per milliliter (ng/mL).
Time frame: The PSA will be measured every three months for each patient 36 months
Vitamin D supplementation and immune cell activity in advanced prostate cancer.
This trial investigates whether vitamin D supplementation influences immune activity. Immune cell counts are reported in cells per microliter (cells/µL).
Time frame: The immune cell counts will be measured at the recruitment after 8 weeks
Plan to share: Yes — The data arising from this study will be compared with a similar clinical trial taking place among African Americans in the USA
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, 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
Data sharing details ↗ · .www.uith.org
Start is estimated for Jun 2026; primary completion for Jun 2028, 24 months later.
Of 139 non-industry phase 3 interventional studies under Prostatic Neoplasms, half reached primary completion within 99 months of starting (the median), counting those still running; a quarter within 57 and three quarters within 144. This study's planned 24 months is below that.
Counting every sponsor, half of 265 studies reached it within 57 months; a quarter within 31 and three quarters within 100.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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