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Randomized Study Of Exercise And Vitamin D In Frail Elderly Subjects

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NCT00249704

Last updated on May 12, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Farmington, Connecticut, 06030-5215 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Frail Elderly
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
75+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Elderly subjects with moderate frailty residing in assisted living facilities.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Presence of progressive, unstable chronic disease; hyperparathyroidism, hypercalcemia.

NCT00249704
Pfizer
Terminated
Randomized Study Of Exercise And Vitamin D In Frail Elderly Subjects

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Randomized Study Of Exercise And Vitamin D In Frail Elderly Subjects
Evaluation of the Effect of a 4-Month Intervention of Exercise and/or Vitamin D on Mobility Function and Strength in Frail Elderly Subjects
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.
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Elderly, Frail
  • Drug: Vitamin D + Sham Exercise
    1000 IU per day of Vitamin D + Sham (equivalent to placebo) Exercise
  • Procedure: Vitamin D Placebo + Exercise
    Vitamin D placebo + Exercise
  • Procedure: Vitamin D Placebo + Sham Exercise
    Vitamin D placebo + Sham (equivalent to placebo) Exercise
  • Drug: Vitamin D + Exercise
    1000 IU per day of Vitamin D + Exercise
  • Experimental: C
    Intervention: Procedure: Vitamin D Placebo + Exercise
  • Experimental: B
    Intervention: Drug: Vitamin D + Sham Exercise
  • Experimental: A
    Intervention: Drug: Vitamin D + Exercise
  • Placebo Comparator: D
    Intervention: Procedure: Vitamin D Placebo + Sham Exercise
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
64
January 2008
Not Provided

Inclusion Criteria:

  • Elderly subjects with moderate frailty residing in assisted living facilities.

Exclusion Criteria:

  • Presence of progressive, unstable chronic disease; hyperparathyroidism, hypercalcemia.
Sexes Eligible for Study: All
75 Years and older   (Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00249704
A9001116
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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