Randomized Study Of Exercise And Vitamin D In Frail Elderly Subjects

Phase 1

Terminated

• Conditions: Elderly, Frail
• Interventions: Procedure: Vitamin D Placebo + Exercise; Procedure: Vitamin D Placebo + Sham Exercise; Drug: Vitamin D + Sham Exercise; Drug: Vitamin D + Exercise

• Registration Number: NCT00249704
• Lead Sponsor: Pfizer

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 Timeline

• Study Start: 2005-10
• Study First Submitted: 2005-11-03
• Study First Submitted QC: 2005-11-04
• Study First Posted: 2005-11-07
• Study Completion: 2008-01
• Status Verified: 2009-01
• Last Update Submitted: 2009-01-07
• Last Update Posted: 2009-01-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
C	Vitamin D Placebo + Exercise	-
D	Vitamin D Placebo + Sham Exercise	-
B	Vitamin D + Sham Exercise	-
A	Vitamin D + Exercise	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 New York, New York, United States