A Study to Assess the Effectiveness of an Investigational Drug in Elderly Subjects With Low Vitamin D Levels (0822A-009)

May 13, 2015 updated by: Merck Sharp & Dohme LLC

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, 16-Week Study to Assess the Effect of Vitamin D3 8400IU Once Weekly on Body Sway and Neuromuscular Function in Men and Women Aged 70 Years or Older

This study will assess the effectiveness of an investigational drug in elderly subjects with low vitamin D levels.

Study Overview

Status

Completed

Conditions

Vitamin D Deficiency

Intervention / Treatment

Drug: MK0822A

Study Type

Interventional

Enrollment (Actual)

216

Phase

Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Man or a woman 70 years old or older in general good health

Exclusion Criteria:

Having any form of neurological impairments that may impair motor function.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mediolateral body sway at 16 weeks. Time Frame: at 16 weeks	at 16 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Functional status assessed using the Short Physical Performance Battery Test determined at 16 weeks. General safety and tolerability at 16 weeks. Time Frame: at 16 weeks	at 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Lips P, Binkley N, Pfeifer M, Recker R, Samanta S, Cohn DA, Chandler J, Rosenberg E, Papanicolaou DA. Once-weekly dose of 8400 IU vitamin D(3) compared with placebo: effects on neuromuscular function and tolerability in older adults with vitamin D insufficiency. Am J Clin Nutr. 2010 Apr;91(4):985-91. doi: 10.3945/ajcn.2009.28113. Epub 2010 Feb 3.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

July 1, 2006

Study Completion (Actual)

July 1, 2006

Study Registration Dates

First Submitted

October 18, 2005

First Submitted That Met QC Criteria