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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00242476

Enrollment

216

Registered

2005-10-20

Start date

2005-09-30

Completion date

2006-07-31

Last updated

2015-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vitamin D Deficiency

Brief summary

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

Interventions

DRUGMK0822A

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

70 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Mediolateral body sway at 16 weeks.	at 16 weeks

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026