NCT00249704

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2005

Typical duration for phase_1

Geographic Reach
1 country

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 3, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 7, 2005

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

January 8, 2009

Status Verified

January 1, 2009

First QC Date

November 3, 2005

Last Update Submit

January 7, 2009

Conditions

Elderly, Frail

Outcome Measures

Primary Outcomes (1)

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

    Throughout trial

Secondary Outcomes (1)

  • 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.

    throughout trial

Study Arms (4)

C

EXPERIMENTAL
Procedure: Vitamin D Placebo + Exercise

B

EXPERIMENTAL
Drug: Vitamin D + Sham Exercise

A

EXPERIMENTAL
Drug: Vitamin D + Exercise

D

PLACEBO COMPARATOR
Procedure: Vitamin D Placebo + Sham Exercise

Interventions

Vitamin D + Sham ExerciseDRUG

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

B
Vitamin D Placebo + ExercisePROCEDURE

Vitamin D placebo + Exercise

C
Vitamin D Placebo + Sham ExercisePROCEDURE

Vitamin D placebo + Sham (equivalent to placebo) Exercise

D
Vitamin D + ExerciseDRUG

1000 IU per day of Vitamin D + Exercise

A

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Pfizer Investigational Site

Farmington, Connecticut, 06030-5215, United States

Location

Pfizer Investigational Site

Hyattsville, Maryland, 20782, United States

Location

Pfizer Investigational Site

Roslindale, Massachusetts, 02131-1011, United States

Location

Pfizer Investigational Site

New York, New York, 10040-3403, United States

Location

Related Links

MeSH Terms

Interventions

Vitamin DExercise

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 3, 2005

First Posted

November 7, 2005

Study Start

October 1, 2005

Study Completion

January 1, 2008

Last Updated

January 8, 2009

Record last verified: 2009-01

Locations

US(4)