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Trial record 1 of 1 for:    NCT00249704
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Randomized Study Of Exercise And Vitamin D In Frail Elderly Subjects

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ClinicalTrials.gov Identifier: NCT00249704
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : November 7, 2005
Last Update Posted : January 8, 2009
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE November 3, 2005
First Posted Date  ICMJE November 7, 2005
Last Update Posted Date January 8, 2009
Study Start Date  ICMJE October 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: February 4, 2008)
Characterization of effect of 4-month exercise and/or Vitamin D intervention on mobility function and strength in frail elderly subjects. [ Time Frame: Throughout trial ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 4, 2005)
Characterization of effect of 4-month exercise and/or Vitamin D intervention on mobility function and strength in frail elderly subjects.
Change History Complete list of historical versions of study NCT00249704 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 7, 2009)
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. [ Time Frame: throughout trial ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 4, 2005)
Evaluation of utility and variability of mobility function tests and biomarekrs, as well as explore the predictors for the exercise and/or Vitamin D intervention response in frail elderly subjects.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomized Study Of Exercise And Vitamin D In Frail Elderly Subjects
Official Title  ICMJE Evaluation of the Effect of a 4-Month Intervention of Exercise and/or Vitamin D on Mobility Function and Strength in Frail Elderly Subjects
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Elderly, Frail
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 4, 2005)
64
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2008
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • Presence of progressive, unstable chronic disease; hyperparathyroidism, hypercalcemia.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 75 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00249704
Other Study ID Numbers  ICMJE A9001116
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP