Randomized Study Of Exercise And Vitamin D In Frail Elderly Subjects

Pfizer

Status and phase: Terminated; Phase 1

Conditions: Elderly, Frail

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00249704

A9001116

Details and patient eligibility

About

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.

Full description

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

Enrollment: 64 patients

Sex: All

Ages: 75+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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64 participants in 4 patient groups, including a placebo group

C

Experimental group

Treatment:

Procedure: Vitamin D Placebo + Exercise

B

Experimental group

Treatment:

Drug: Vitamin D + Sham Exercise

A

Experimental group

Treatment:

Drug: Vitamin D + Exercise

D

Placebo Comparator group

Treatment:

Procedure: Vitamin D Placebo + Sham Exercise