Physical Function Clinical Trial
Official title:
Role of Vitamin D Status on Physical Function and Falls in Adults of Advanced Age
NCT number | NCT00710957 |
Other study ID # | IRB00005739 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 2008 |
Est. completion date | February 2011 |
Verified date | July 2018 |
Source | Wake Forest University Health Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Projections from NHANES III indicate that approximately 12,000,000 U.S. adults ≥ 60 years of
age have vitamin D insufficiency (serum 25(OH)D < 50 nmol/L). A growing body of evidence
suggests that vitamin D status may be important in biologic processes involved in the
maintenance of physical function. To test the hypothesis that vitamin D insufficiency is
associated with poorer muscle strength and physical performance, we propose to evaluate the
role of vitamin D status (serum 25(OH)D) on physical function and falls in the CHS All Stars
cohort, a population of advanced age. The specific aims are as follows:
Specific Aim 1. To describe the prevalence and correlates of vitamin D insufficiency in
adults of advanced age.
Specific Aim 2. To examine the cross-sectional association between vitamin D status and
muscle strength (leg and grip strength), physical performance (3 m/15 ft walk time, repeated
chair stands, and standing balance), self-reported physical function (mobility, ADL and IADL
disability), and falls.
Specific Aim 3. To examine the longitudinal association between vitamin D status at baseline
and incident disability (mobility, ADL and IADL disability) over 3 years of follow-up.
Research Hypotheses: Low vitamin D status (25(OH)D < 50 nmol/L) will be associated with (a)
lower levels of muscle strength and physical performance; (b) higher levels of self-reported
limitations in physical function and falls; and (c) greater odds of incident disability.
Status | Completed |
Enrollment | 1100 |
Est. completion date | February 2011 |
Est. primary completion date | February 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 79 Years and older |
Eligibility |
Inclusion Criteria: - Participant in the main CHS study Exclusion Criteria: - Not willing to give consent |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Wake Forest University Health Sciences | Merck Sharp & Dohme Corp. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To examine the association between vitamin D status and muscle strength (leg, grip strength), physical performance (3m/15 ft walk time, repeated chair stands, and balance), self-reported physical function (mobility, ADL and IADL disability), and falls. | At the year 18 visit of the CHS study | ||
Primary | To examine the longitudinal association between vitamin D status at baseline and incident disability (mobility, ADL and IADL disability) over 3 years of follow-up. | Years 18 - 21 of CHS Study | ||
Secondary | To describe the prevalence and correlates of vitamin D insufficiency in adults of advanced age. | Year 18 of CHS study |
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