Prostatic NeoplasmsNCT02064946
High-dose Vitamin D Supplementation for ADT-induced Side Effects
A study testing vitamin D in people with Prostatic Neoplasms and Bone Mineral Density Quantitative Trait Locus 3, run by University of Rochester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 99 years, men only
- Conditions the study is for
- Prostatic Neoplasms, Bone Mineral Density Quantitative Trait Locus 3
- What is being tested?
- vitamin D
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 99 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wilmot Cancer Center, University of Rochester
Rochester, New York, 14624
About this study
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.
Read the 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.
- Being tested
- vitamin D, Placebo
- Keywords
- prostate cancer, bone density, vitamin D, micronutrients, pharmacologic actions
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin DDietary supplement
50,000IU/week of vitamin D3
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: vitamin D |
| 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
bone mineral density
mean difference in bone mineral density between treatment group and control group
Measured: after 24 weeks
bone biomarkers
amino-terminal collagen crosslinks (NTx) and bone-specific alkaline phosphatase (BSAP)
Measured: after 24 weeks
Secondary outcomes (3)
muscle mass
muscle mass as assessed by dual energy x-ray absorptiometry
Measured: after 24 weeks
muscular strength
as assessed by Handgrip Dynamometer and 7-10 Repetition Maximum
Measured: after 24 weeks
physical performance
as assessed by falls, physical performance battery, and 6-min walk test
Measured: after 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2014 (estimated)
- Study startMar 2014
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luke Peppone, University of Rochester
- Investigators
- Luke J Peppone, PhD, MPH, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02064946
- Sponsor's protocol ID
- 1R21CA175793-01A1
- Status last verified
- Apr 2019
- First submitted
- 14 Feb 2014
- Last updated
- 8 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 32911988
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-dose Vitamin D Supplementation for ADT-induced Side Effects
- ClinicalTrials.gov ID
- NCT02064946
- Acronym / sponsor ID
- 1R21CA175793-01A1
- Keywords
- prostate cancer, bone density, vitamin D, micronutrients, pharmacologic actions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- Mar 2014 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 17 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D3 | Active comparator | Dietary Supplement: vitamin DVitamin 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 | Placebo comparator | Dietary Supplement: PlaceboControl: 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. |
Who may qualify
- Ages
- 60 to 99 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vitamin D50,000IU/week of vitamin D3 | Dietary supplement | Vitamin D3 |
| Placebo | Dietary supplement | Control |
Primary outcome
bone mineral density
Time frame: after 24 weeks
mean difference in bone mineral density between treatment group and control group
bone biomarkers
Time frame: after 24 weeks
amino-terminal collagen crosslinks (NTx) and bone-specific alkaline phosphatase (BSAP)
3 secondary outcomes
muscle mass
Time frame: after 24 weeks
muscular strength
Time frame: after 24 weeks
physical performance
Time frame: after 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2019.
- Derived from this study: PubMed 32911988Inglis 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luke J Peppone, PhD, MPH principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vitamin D in people with Prostatic Neoplasms and Bone Mineral Density Quantitative Trait Locus 3, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bone mineral density (time frame: after 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02064946, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2019.