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Randomized Study Of Exercise And Vitamin D In Frail Elderly Subjects

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00249704
First received: November 3, 2005
Last updated: January 7, 2009
Last verified: January 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Elderly, Frail
 Drug: Vitamin D + Sham Exercise
Procedure: Vitamin D Placebo + Exercise
Procedure: Vitamin D Placebo + Sham Exercise
Drug: Vitamin D + Exercise
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of the Effect of a 4-Month Intervention of Exercise and/or Vitamin D on Mobility Function and Strength in Frail Elderly Subjects

Resource links provided by NLM:

Drug Information available for: Vitamin D
U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 64
Study Start Date: October 2005
Study Completion Date: January 2008
Arms Assigned Interventions
Experimental: C Procedure: Vitamin D Placebo + Exercise
Vitamin D placebo + Exercise
Experimental: B Drug: Vitamin D + Sham Exercise
1000 IU per day of Vitamin D + Sham (equivalent to placebo) Exercise
Experimental: A Drug: Vitamin D + Exercise
1000 IU per day of Vitamin D + Exercise
Placebo Comparator: D Procedure: Vitamin D Placebo + Sham Exercise
Vitamin D placebo + Sham (equivalent to placebo) Exercise

Detailed Description:

The study was terminated on 10Jan2008. This was a strategic decision not related to safety, efficacy, or feasibility of trial.

  Eligibility

Ages Eligible for Study:   75 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Presence of progressive, unstable chronic disease; hyperparathyroidism, hypercalcemia.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00249704

Locations
United States, Connecticut
Pfizer Investigational Site
Farmington, Connecticut, United States, 06030-5215
United States, Maryland
Pfizer Investigational Site
Hyattsville, Maryland, United States, 20782
United States, Massachusetts
Pfizer Investigational Site
Roslindale, Massachusetts, United States, 02131-1011
United States, New York
Pfizer Investigational Site
New York, New York, United States, 10040-3403
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00249704     History of Changes
Other Study ID Numbers: A9001116
Study First Received: November 3, 2005
Last Updated: January 7, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Vitamin D
Ergocalciferols
Vitamins
Bone Density Conservation Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 23, 2013