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

Tracking Information

First Received Date ^ICMJE

November 3, 2005

Last Updated Date

January 7, 2009

Start Date ^ICMJE

October 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Characterization of effect of 4-month exercise and/or Vitamin D intervention on mobility function and strength in frail elderly subjects.

Change History

Complete list of historical versions of study NCT00249704 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Evaluation of utility and variability of mobility function tests and biomarekrs, as well as explore the predictors for the exercise and/or Vitamin D intervention response in frail elderly subjects.

Descriptive Information

Brief Title ^ICMJE

Randomized Study Of Exercise And Vitamin D In Frail Elderly Subjects

Official Title ^ICMJE

Evaluation of the Effect of a 4-Month Intervention of Exercise and/or Vitamin D on Mobility Function and Strength in Frail Elderly Subjects

Brief Summary

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.

Detailed Description

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

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Elderly, Frail

Intervention ^ICMJE

Drug: Vitamin D + Sham Exercise
Procedure: Vitamin D Placebo + Exercise
Procedure: Vitamin D Placebo + Sham Exercise
Drug: Vitamin D + Exercise

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

January 2008

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Elderly subjects with moderate frailty residing in assisted living facilities.

Exclusion Criteria:

Presence of progressive, unstable chronic disease; hyperparathyroidism, hypercalcemia.

Gender

Both

Ages

75 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00249704

Responsible Party

Director, Clinical Trial Disclosure Group, Pfizer, Inc.

Study ID Numbers ^ICMJE

A9001116

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

January 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP