Randomized Study Of Exercise And Vitamin D In Frail Elderly Subjects

NCT ID: NCT00249704

Last Updated: 2009-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2008-01-31

Brief Summary

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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

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

Conditions

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Elderly, Frail

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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C

Group Type EXPERIMENTAL

Vitamin D Placebo + Exercise

Intervention Type PROCEDURE

Vitamin D placebo + Exercise

B

Group Type EXPERIMENTAL

Vitamin D + Sham Exercise

Intervention Type DRUG

1000 IU per day of Vitamin D + Sham (equivalent to placebo) Exercise

A

Group Type EXPERIMENTAL

Vitamin D + Exercise

Intervention Type DRUG

1000 IU per day of Vitamin D + Exercise

D

Group Type PLACEBO_COMPARATOR

Vitamin D Placebo + Sham Exercise

Intervention Type PROCEDURE

Vitamin D placebo + Sham (equivalent to placebo) Exercise

Interventions

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Vitamin D + Sham Exercise

1000 IU per day of Vitamin D + Sham (equivalent to placebo) Exercise

Intervention Type DRUG

Vitamin D Placebo + Exercise

Vitamin D placebo + Exercise

Intervention Type PROCEDURE

Vitamin D Placebo + Sham Exercise

Vitamin D placebo + Sham (equivalent to placebo) Exercise

Intervention Type PROCEDURE

Vitamin D + Exercise

1000 IU per day of Vitamin D + Exercise

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Elderly subjects with moderate frailty residing in assisted living facilities.

Exclusion Criteria

* Presence of progressive, unstable chronic disease; hyperparathyroidism, hypercalcemia.
Minimum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Farmington, Connecticut, United States

Site Status

Pfizer Investigational Site

Hyattsville, Maryland, United States

Site Status

Pfizer Investigational Site

Roslindale, Massachusetts, United States

Site Status

Pfizer Investigational Site

New York, New York, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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A9001116

Identifier Type: -

Identifier Source: org_study_id

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