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

Vitamin D Deficiency Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00242476
• Other study ID #: 0822A-009
• Secondary ID: MK0822A-0092005_
• Status: Completed
• Phase: Phase 2
• First received: October 18, 2005
• Last updated: May 13, 2015
• Start date: September 2005
• Est. completion date: July 2006

Study information

• Verified date: May 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: July 2006
• Est. primary completion date: July 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 70 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Vitamin D Deficiency

Intervention

Drug:
• MK0822A

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mediolateral body sway at 16 weeks.		at 16 weeks	No
Secondary	Functional status assessed using the Short Physical Performance Battery Test determined at 16 weeks. General safety and tolerability at 16 weeks.		at 16 weeks	Yes