- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00710957
Vitamin D and Physical Function in Older Adults
Role of Vitamin D Status on Physical Function and Falls in Adults of Advanced Age
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Participant in the main CHS study
Exclusion Criteria:
- Not willing to give consent
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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CHS All Stars
CHS All Stars is an ancillary study of the Cardiovascular Health Study (CHS), a longitudinal, observational, population-based study of the onset, progression, and course of heart disease and stroke in the elderly which began in 1988.
The All Stars study reexamined the survivors of CHS to determine the likelihood of maintaining function later in life.
A focus was to determine whether age-related biological factors are long-term predicators of functional aging which was assessed through a follow-up exam (Yr 18 visit conducted in 2005-06, n=1674 older adults, mean age =84 years) and 3 yrs of subsequent 6 month interval phone contacts.
Vitamin D status (serum 25(OH)D and PTH) is being assessed in all CHS All Stars participants who provided a blood sample at the Yr 18 visit (n~1100).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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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.
Time Frame: At the year 18 visit of the CHS study
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At the year 18 visit of the CHS study
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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.
Time Frame: Years 18 - 21 of CHS Study
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Years 18 - 21 of CHS Study
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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To describe the prevalence and correlates of vitamin D insufficiency in adults of advanced age.
Time Frame: Year 18 of CHS study
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Year 18 of CHS study
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Collaborators and Investigators
Collaborators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IRB00005739
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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