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See termination reason in detailed description.
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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.
The study was terminated on 10Jan2008. This was a strategic decision not related to safety, efficacy, or feasibility of trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| C | Experimental |
| |
| B | Experimental |
| |
| A | Experimental |
| |
| D | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D + Sham Exercise | Drug | 1000 IU per day of Vitamin D + Sham (equivalent to placebo) Exercise |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Characterization of effect of 4-month exercise and/or Vitamin D intervention on mobility function and strength in frail elderly subjects. | Throughout trial |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Farmington | Connecticut | 06030-5215 | United States | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| Vitamin D Placebo + Exercise |
| Procedure |
Vitamin D placebo + Exercise |
|
| Vitamin D Placebo + Sham Exercise | Procedure | Vitamin D placebo + Sham (equivalent to placebo) Exercise |
|
| Vitamin D + Exercise | Drug | 1000 IU per day of Vitamin D + Exercise |
|
| Hyattsville |
| Maryland |
| 20782 |
| United States |
| Pfizer Investigational Site | Roslindale | Massachusetts | 02131-1011 | United States |
| Pfizer Investigational Site | New York | New York | 10040-3403 | United States |
| D009043 |
| Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |