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The purpose of this study is to test the efficacy of a high-dose vitamin D supplementation regimen in reducing androgen deprivation therapy (ADT)-related side effects in older prostate cancer patients on ADT. The proposed study is a randomized, double-blind, 2-arm, controlled clinical trial that will accrue 76 prostate cancer patients without severe bone loss, aged 60 and older, beginning ADT, and scheduled to receive at least 6 months more of ADT. Participants will be randomized to: 1) weekly high-dose vitamin D3 (50,000 IU) or 2) vitamin D placebo only for a period of 24 weeks. Both groups will also receive a daily multivitamin and calcium supplement.
The investigators hypothesize high-dose vitamin D supplementation will reduce androgen deprivation therapy (ADT)-related side effects including ADT-induced bone loss, decreased muscle mass, falls, reduced muscle strength, and diminished physical performance in older prostate cancer patients. The vitamin D supplementation is aimed at reducing fracture risk by maintaining proper bone density, thereby preventing osteoporotic/osteopenic conditions and increasing muscle mass. Both vitamin D and exercise are efficacious in maintaining proper bone health and muscle mass among the general population, but little research has been done on prostate cancer patients and survivors. Vitamin D could reduce fracture risk among prostate cancer survivors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D3 | Active Comparator | Vitamin D3 50,000 IU: Patients will be assigned to receive weekly high-dose vitamin D (50,000 IU/week) along with a daily multivitamin (600 IU/day vitamin D + 210 mg/day calcium) and calcium supplements (1,000 mg/day calcium) for a period of 24 weeks. |
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| Control | Placebo Comparator | Control: Patients will be assigned to receive a weekly vitamin D placebo along with a daily multivitamin (600 IU/day vitamin D + 210 mg/day calcium)and calcium supplements (1,000 mg/day calcium) for a period of 24 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vitamin D | Dietary Supplement | 50,000IU/week of vitamin D3 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| bone mineral density | mean difference in bone mineral density between treatment group and control group | after 24 weeks |
| bone biomarkers | amino-terminal collagen crosslinks (NTx) and bone-specific alkaline phosphatase (BSAP) | after 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| muscle mass | muscle mass as assessed by dual energy x-ray absorptiometry | after 24 weeks |
| muscular strength | as assessed by Handgrip Dynamometer and 7-10 Repetition Maximum |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luke J Peppone, PhD, MPH | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wilmot Cancer Center, University of Rochester | Rochester | New York | 14624 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32911988 | Derived | Inglis JE, Fernandez ID, van Wijngaarden E, Culakova E, Reschke JE, Kleckner AS, Lin PJ, Mustian KM, Peppone LJ. Effects of High-Dose Vitamin D Supplementation on Phase Angle and Physical Function in Patients with Prostate Cancer on ADT. Nutr Cancer. 2021;73(10):1882-1889. doi: 10.1080/01635581.2020.1819348. Epub 2020 Sep 11. |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| Placebo |
| Dietary Supplement |
|
| after 24 weeks |
| physical performance | as assessed by falls, physical performance battery, and 6-min walk test | after 24 weeks |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |