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

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00242476
First received: October 18, 2005
Last updated: January 14, 2010
Last verified: January 2010
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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:

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D
U.S. FDA Resources

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

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  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 by Merck

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00242476     History of Changes
Other Study ID Numbers: 2005_089, MK0822A-009
Study First Received: October 18, 2005
Last Updated: January 14, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
 Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 23, 2013