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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.)
Information provided by:
Pfizer Identifier:
First received: November 3, 2005
Last updated: January 7, 2009
Last verified: January 2009
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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, 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 ]

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 ]

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.

Ages Eligible for Study:   75 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00249704

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
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00249704     History of Changes
Other Study ID Numbers: A9001116
Study First Received: November 3, 2005
Last Updated: January 7, 2009

Additional relevant MeSH terms:
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents processed this record on May 25, 2017