A Study to Assess the Effectiveness of an Investigational Drug in Elderly Subjects With Low Vitamin D Levels.
This study has been completed.
Information provided by:
First received: October 18, 2005
Last updated: January 14, 2010
Last verified: January 2010
This study will assess the effectiveness of an investigational drug in elderly subjects with low vitamin D levels.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||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|
Resource links provided by NLM:
Further study details as provided by Merck:
Primary Outcome Measures:
- Mediolateral body sway at 16 weeks. [ Time Frame: at 16 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Functional status assessed using the Short Physical Performance Battery Test determined at 16 weeks. General safety and tolerability at 16 weeks. [ Time Frame: at 16 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2005|
|Study Completion Date:||July 2006|
|Primary Completion Date:||July 2006 (Final data collection date for primary outcome measure)|
Contacts and Locations