Randomized Study Of Exercise And Vitamin D In Frail Elderly Subjects
Phase 1
Terminated
- Conditions
- Elderly, Frail
- Interventions
- Procedure: Vitamin D Placebo + ExerciseProcedure: Vitamin D Placebo + Sham ExerciseDrug: Vitamin D + Sham ExerciseDrug: Vitamin D + Exercise
- Registration Number
- NCT00249704
- Lead Sponsor
- Pfizer
- Brief Summary
The study will explore multiple mobility function tests as well as functional and neuropsychological tests in elderly subjects at risk for falls and disability, before and after 4-month exercise and/or Vitamin D intervention.
- Detailed Description
The study was terminated on 10Jan2008. This was a strategic decision not related to safety, efficacy, or feasibility of trial.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 64
Inclusion Criteria
- Elderly subjects with moderate frailty residing in assisted living facilities.
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Exclusion Criteria
- Presence of progressive, unstable chronic disease; hyperparathyroidism, hypercalcemia.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description C Vitamin D Placebo + Exercise - D Vitamin D Placebo + Sham Exercise - B Vitamin D + Sham Exercise - A Vitamin D + Exercise -
- Primary Outcome Measures
Name Time Method Characterization of effect of 4-month exercise and/or Vitamin D intervention on mobility function and strength in frail elderly subjects. Throughout trial
- Secondary Outcome Measures
Name Time Method Evaluation of utility and variability of mobility function tests and biomarkers, as well as explore the predictors for the exercise and/or Vitamin D intervention response in frail elderly subjects. throughout trial
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸New York, New York, United States