A Study to Assess the Effectiveness of an Investigational Drug in Elderly Subjects With Low Vitamin D Levels (0822A-009)
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
3 other identifiers
interventional
216
0 countries
N/A
Brief Summary
This study will assess the effectiveness of an investigational drug in elderly subjects with low vitamin D levels.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2005
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
October 18, 2005
CompletedFirst Posted
Study publicly available on registry
October 20, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2006
CompletedMay 14, 2015
May 1, 2015
10 months
October 18, 2005
May 13, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Mediolateral body sway at 16 weeks.
at 16 weeks
Secondary Outcomes (1)
Functional status assessed using the Short Physical Performance Battery Test determined at 16 weeks. General safety and tolerability at 16 weeks.
at 16 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Man or a woman 70 years old or older in general good health
You may not qualify if:
- Having any form of neurological impairments that may impair motor function.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Lips P, Binkley N, Pfeifer M, Recker R, Samanta S, Cohn DA, Chandler J, Rosenberg E, Papanicolaou DA. Once-weekly dose of 8400 IU vitamin D(3) compared with placebo: effects on neuromuscular function and tolerability in older adults with vitamin D insufficiency. Am J Clin Nutr. 2010 Apr;91(4):985-91. doi: 10.3945/ajcn.2009.28113. Epub 2010 Feb 3.
PMID: 20130093DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Merck Sharp & Dohme LLC
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 18, 2005
First Posted
October 20, 2005
Study Start
September 1, 2005
Primary Completion
July 1, 2006
Study Completion
July 1, 2006
Last Updated
May 14, 2015
Record last verified: 2015-05