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

Sponsored by:	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

MedlinePlus related topics: Exercise and Physical Fitness

Drug Information available for: Vitamin D Ergocalciferol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
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

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
C: Experimental	Procedure: Vitamin D Placebo + Exercise Vitamin D placebo + Exercise
B: Experimental	Drug: Vitamin D + Sham Exercise 1000 IU per day of Vitamin D + Sham (equivalent to placebo) Exercise
A: Experimental	Drug: Vitamin D + Exercise 1000 IU per day of Vitamin D + Exercise
D: Placebo Comparator	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

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

Link to ClinicalStudyResults.org Posting: This link exits the ClinicalTrials.gov site

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

Study placed in the following topic categories:

Vitamin D
Clotrimazole
Miconazole

Tioconazole
Ergocalciferols
Salicylhydroxamic acid

Additional relevant MeSH terms:

Trypanocidal Agents
Anti-Infective Agents
Antiparasitic Agents
Antiprotozoal Agents
Therapeutic Uses
Antifungal Agents

Growth Substances
Vitamins
Physiological Effects of Drugs
Bone Density Conservation Agents
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009