A Study to Assess the Effectiveness of an Investigational Drug in Elderly Subjects With Low Vitamin D Levels.

This study has been completed.

First Received: October 18, 2005 Last Updated: June 10, 2009 History of Changes

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00242476

Purpose

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

Condition	Intervention	Phase
Vitamin D Deficiency	Drug: MK0822A	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	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

Resource links provided by NLM:

Drug Information available for: Vitamin D

Further study details as provided by Merck:

Primary Outcome Measures:

Mediolateral body sway at 16 weeks. [ Time Frame: at 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Enrollment:	216
Study Start Date:	September 2005
Study Completion Date:	July 2006
Primary Completion Date:	July 2006 (Final data collection date for primary outcome measure)

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00242476

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2005_089, 0822A-009
Study First Received:	October 18, 2005
Last Updated:	June 10, 2009
ClinicalTrials.gov Identifier:	NCT00242476 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Vitamin D Deficiency
Cholecalciferol
Vitamin D
Malnutrition
Vitamin D3

Avitaminosis
Vitamins
Nutrition Disorders
Calciferol
Deficiency Diseases

Additional relevant MeSH terms:

Vitamin D Deficiency
Malnutrition
Avitaminosis
Nutrition Disorders
Deficiency Diseases

ClinicalTrials.gov processed this record on September 10, 2009