Randomized Study Of Exercise And Vitamin D In Frail Elderly Subjects - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00249704

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 I

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:

MedlinePlus related topics: Exercise and Physical Fitness Vitamin D

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 February 09, 2012