High-dose Vitamin D Supplementation for ADT-induced Side Effects

Prostatic Neoplasms Clinical Trial

Official title:

High-dose Vitamin D Supplementation for ADT-induced Side Effects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02064946
• Other study ID #: 1R21CA175793-01A1
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Est. completion date: November 2016

Study information

• Verified date: April 2019
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 60 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bone Mineral Density Quantitative Trait Locus 3
• Osteoporosis
• Prostatic Neoplasms

Intervention

Dietary Supplement:
• vitamin D
50,000IU/week of vitamin D3
• Placebo

Locations

Country	Name	City	State
United States	Wilmot Cancer Center, University of Rochester	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bone mineral density	mean difference in bone mineral density between treatment group and control group	after 24 weeks
Primary	bone biomarkers	amino-terminal collagen crosslinks (NTx) and bone-specific alkaline phosphatase (BSAP)	after 24 weeks
Secondary	muscle mass	muscle mass as assessed by dual energy x-ray absorptiometry	after 24 weeks
Secondary	muscular strength	as assessed by Handgrip Dynamometer and 7-10 Repetition Maximum	after 24 weeks
Secondary	physical performance	as assessed by falls, physical performance battery, and 6-min walk test	after 24 weeks