Back to resultsHigh-dose Vitamin D Supplementation for ADT-induced Side Effects
Primary Purpose
Prostatic Neoplasms, Bone Mineral Density Quantitative Trait Locus 3
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
vitamin D
Placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Prostatic Neoplasms focused on measuring prostate cancer, bone density, vitamin D, micronutrients, pharmacologic actions
Eligibility Criteria
Inclusion Criteria:
- Have a confirmed diagnosis of stage I-IIIA prostate cancer
- Within 6 months of starting ADT with an additional 6 more months planned.
- Participants must have sub-optimal vitamin D levels of <32 ng/ml.
- Participants must agree not to take calcium and/or vitamin D supplements for the duration of the intervention other than those provided.
- Participants must have an ionized serum calcium level within normal limits (1.19-1.29mmol/L) and a total corrected serum calcium of ≤10.5 mg/dl.
- No contraindications for fitness testing and no physical limitations (e.g. cardiorespiratory, orthopedic, nervous system) as assessed by their physician.
- Able to read English (since the assessment materials are in printed format).
- Able to swallow medication and provide written informed consent.
- 60 years of age or older.
Exclusion Criteria:
- Previously verified diagnosis of osteoporosis (any t-score ≤ -2.5).
- Patients on antiresorptive drugs (i.e. bisphosphonates) within the past year.
- Patients with hypercalcemia (corrected serum Ca > 10.5 mg/dl) or a history of hypercalcemia or vitamin D toxicity/sensitivity.
- Patients with impaired renal function (CrCl < 60 mL/min) or who had kidney stones (calcium salt) within the past 5 years.
- Myocardial infarction within the past year.
Sites / Locations
- Wilmot Cancer Center, University of Rochester
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Vitamin D3
Control
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
bone mineral density
mean difference in bone mineral density between treatment group and control group
bone biomarkers
amino-terminal collagen crosslinks (NTx) and bone-specific alkaline phosphatase (BSAP)
Secondary Outcome Measures
muscle mass
muscle mass as assessed by dual energy x-ray absorptiometry
muscular strength
as assessed by Handgrip Dynamometer and 7-10 Repetition Maximum
physical performance
as assessed by falls, physical performance battery, and 6-min walk test
Full Information
NCT ID
NCT02064946
First Posted
February 14, 2014
Last Updated
April 4, 2019
Sponsor
University of Rochester
1. Study Identification
Unique Protocol Identification Number
NCT02064946
Brief Title
High-dose Vitamin D Supplementation for ADT-induced Side Effects
Official Title
High-dose Vitamin D Supplementation for ADT-induced Side Effects
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
March 2014 (Actual)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms, Bone Mineral Density Quantitative Trait Locus 3
Keywords
prostate cancer, bone density, vitamin D, micronutrients, pharmacologic actions
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
108 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vitamin D3
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
vitamin D
Intervention Description
50,000IU/week of vitamin D3
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
bone mineral density
Description
mean difference in bone mineral density between treatment group and control group
Time Frame
after 24 weeks
Title
bone biomarkers
Description
amino-terminal collagen crosslinks (NTx) and bone-specific alkaline phosphatase (BSAP)
Time Frame
after 24 weeks
Secondary Outcome Measure Information:
Title
muscle mass
Description
muscle mass as assessed by dual energy x-ray absorptiometry
Time Frame
after 24 weeks
Title
muscular strength
Description
as assessed by Handgrip Dynamometer and 7-10 Repetition Maximum
Time Frame
after 24 weeks
Title
physical performance
Description
as assessed by falls, physical performance battery, and 6-min walk test
Time Frame
after 24 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have a confirmed diagnosis of stage I-IIIA prostate cancer
Within 6 months of starting ADT with an additional 6 more months planned.
Participants must have sub-optimal vitamin D levels of <32 ng/ml.
Participants must agree not to take calcium and/or vitamin D supplements for the duration of the intervention other than those provided.
Participants must have an ionized serum calcium level within normal limits (1.19-1.29mmol/L) and a total corrected serum calcium of ≤10.5 mg/dl.
No contraindications for fitness testing and no physical limitations (e.g. cardiorespiratory, orthopedic, nervous system) as assessed by their physician.
Able to read English (since the assessment materials are in printed format).
Able to swallow medication and provide written informed consent.
60 years of age or older.
Exclusion Criteria:
Previously verified diagnosis of osteoporosis (any t-score ≤ -2.5).
Patients on antiresorptive drugs (i.e. bisphosphonates) within the past year.
Patients with hypercalcemia (corrected serum Ca > 10.5 mg/dl) or a history of hypercalcemia or vitamin D toxicity/sensitivity.
Patients with impaired renal function (CrCl < 60 mL/min) or who had kidney stones (calcium salt) within the past 5 years.
Myocardial infarction within the past year.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luke J Peppone, PhD, MPH
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wilmot Cancer Center, University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14624
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32911988
Citation
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.
Results Reference
derived
Learn more about this trial
High-dose Vitamin D Supplementation for ADT-induced Side Effects
We'll reach out to this number within 24 hrs