NCT00242476CompletedPhase 2
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, 16-Week Study to Assess the Effect of Vitamin D3 8400IU Once Weekly on Body Sway and Neuromuscular Function in Men and Women Aged 70 Years or Older
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 216
- Primary Endpoint
- Mediolateral body sway at 16 weeks.
Study Overview
Brief Summary
This study will assess the effectiveness of an investigational drug in elderly subjects with low vitamin D levels.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 70 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Man or a woman 70 years old or older in general good health
Exclusion Criteria
- •Having any form of neurological impairments that may impair motor function.
Outcomes
Primary Outcomes
Mediolateral body sway at 16 weeks.
Time Frame: at 16 weeks
Secondary Outcomes
- Functional status assessed using the Short Physical Performance Battery Test determined at 16 weeks. General safety and tolerability at 16 weeks.(at 16 weeks)
Investigators
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