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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

Must not have

Currently taking a vitamin D or multivitamin supplement, that has more than 400 IU/10mcg of vitamin D daily for the past month

End stage renal failure on dialysis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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I have had prostate cancer before, whether it was localized, spread, or came back.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been taking vitamin D or a multivitamin with over 400 IU of vitamin D daily for the last month.

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I am on dialysis for end-stage kidney failure.

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I have liver cirrhosis.

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I have had high calcium levels in my blood.

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I haven't had chemotherapy, surgery, or radiation in the last 3 weeks.

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I am legally able and mentally fit to participate in this study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 more

Side effects data

From 2010 Phase 4 trial • 109 Patients • NCT01265615

23%

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

Viral Infection

Leg Cramps

Hypercalcemia

Allergic Infection

Polydipsia

Dehydration

Urinary Tract Infection

Chest Pain

Sinusitis

Headache

General Infection

Asthenia

Fever

Infection Fungal

Conjuctivitis

Syncope

Depression

Increased Cough

Polyuria

Abdominal Pain

Photophobia

Decreased libido

Hypotension

Nausea

Esophageal ulcer

Somnolence

Back Pain

Vomiting

Pruritus

100%

80%

60%

40%

20%

Study treatment Arm

Paricalcitol Treatment

Calcitriol Treatment

Cholecalciferol

Supplemental

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Cholecalciferol

2014

Completed Phase 4

~1100

Biospecimen Collection

2004

Completed Phase 3

~2030