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Vitamin D Replacement
Vitamin D for Prostate Cancer
Phase < 1
Recruiting
Led By Gerardo Colon-Otero, M.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with a previous history of localized or metastatic or locally recurrent prostate cancer
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is testing if vitamin D deficiency contributes to more aggressive prostate cancer, and if replacing vitamin D can normalize the immune function.
Who is the study for?
This trial is for African American males aged 18 or older with a history of localized or metastatic prostate cancer and low vitamin D levels. They must be willing to visit the Mayo Clinic for blood collection at the start and after 8 weeks. Those with hypercalcemia, end-stage renal failure, current high-dose vitamin D intake, recent chemotherapy/surgery/radiation, hypersensitivity to vitamin D, liver cirrhosis, or legal/medical issues affecting consent are excluded.Check my eligibility
What is being tested?
The study investigates how common vitamin D insufficiency is among Black/African American prostate cancer patients and its effect on immune function. It also examines whether supplementing with cholecalciferol (vitamin D) normalizes immune responses. Participants will undergo quality-of-life assessments as part of the study.See study design
What are the potential side effects?
Potential side effects from taking cholecalciferol may include elevated calcium levels in the blood which can cause weakness, fatigue, nausea, vomiting, confusion; however these are generally rare when taken under medical supervision.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had prostate cancer before, whether it was localized, spread, or came back.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Acceptability of vitamin D replacement therapy among Black/AA patients with prostate cancer
Differences in peripheral blood immunological function among Black / African American (AA) patients with localized prostate cancer versus metastatic or locally recurrent prostate cancer
Effects of vitamin D replacement on the peripheral blood cells' immunological function
+3 moreSide effects data
From 2010 Phase 4 trial • 109 Patients • NCT0126561523%
Hypophospatemia
17%
Fatigue
13%
Increased hypertension
13%
Edema
13%
Diarrhea
13%
Pain
10%
Taste perversions
10%
Arthritis
10%
Dizziness
10%
Gastroenteritis
10%
Vertigo
10%
Rhinitis
10%
Bronchitis
10%
Rash
7%
Viral Infection
7%
Leg Cramps
7%
Hypercalcemia
7%
Allergic Infection
7%
Polydipsia
7%
Dehydration
7%
Urinary Tract Infection
3%
Chest Pain
3%
Sinusitis
3%
Headache
3%
General Infection
3%
Asthenia
3%
Fever
3%
Infection Fungal
3%
Conjuctivitis
3%
Syncope
3%
Depression
3%
Increased Cough
3%
Polyuria
3%
Abdominal Pain
3%
Photophobia
3%
Decreased libido
3%
Hypotension
3%
Nausea
3%
Esophageal ulcer
3%
Somnolence
3%
Back Pain
3%
Vomiting
3%
Pruritus
100%
80%
60%
40%
20%
0%
Study treatment Arm
Paricalcitol Treatment
Calcitriol Treatment
Cholecalciferol
Supplemental
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (cholecalciferol)Experimental Treatment3 Interventions
Patients with low vitamin D3 levels receive cholecalciferol PO daily for 8 weeks in the absence of unacceptable toxicity. Patients undergo blood sample collection throughout the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1730
Cholecalciferol
2014
Completed Phase 4
~1100
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,923,872 Total Patients Enrolled
561 Trials studying Prostate Cancer
507,095 Patients Enrolled for Prostate Cancer
Mayo ClinicLead Sponsor
3,207 Previous Clinical Trials
3,766,460 Total Patients Enrolled
34 Trials studying Prostate Cancer
8,388 Patients Enrolled for Prostate Cancer
Gerardo Colon-Otero, M.D.Principal InvestigatorMayo Clinic
3 Previous Clinical Trials
386 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had prostate cancer before, whether it was localized, spread, or came back.I have been taking vitamin D or a multivitamin with over 400 IU of vitamin D daily for the last month.I am on dialysis for end-stage kidney failure.I have liver cirrhosis.I have had high calcium levels in my blood.I haven't had chemotherapy, surgery, or radiation in the last 3 weeks.I am an African American male aged 18 or older.I am legally able and mentally fit to participate in this study.I am willing to visit Mayo Clinic for initial and follow-up blood tests.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (cholecalciferol)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are being monitored as part of this clinical experiment?
"Affirmative, the data on clinicaltrials.gov suggests that this medical study is actively recruiting and was initially posted on November 10th 2021. Approximately 200 participants are needed from 1 site in total."
Answered by AI
Are there currently open spots for people to join this medical trial?
"Affirmative. According to the records on clinicaltrials.gov, this medical trial is recruiting patients and was initially posted on November 10th 2021; it has since been updated on December 1st. The protocol requires 200 participants from one site in order for the study to continue."
Answered by AI
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