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
  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:


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:
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 April 16, 2014