Clinical trial · Interventional
High-dose Vitamin D Supplementation for ADT-induced Side Effects
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bone Mineral Density Quantitative Trait Locus 3 | — | UNRESOLVED | — |
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Dietary Supplement | — | UNRESOLVED |
| vitamin D | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Vitamin D3
- 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.
- interventionNames
- Dietary Supplement: vitamin D
- type
- PLACEBO_COMPARATOR
- label
- Control
- 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.
- interventionNames
- Dietary Supplement: Placebo
Primary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 60 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDInglis 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. PMID 32911988