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

Completed

Study Type

Observational

Enrollment (Actual)

1100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

79 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Cardiovascular Health Study (CHS), is a longitudinal, observational, population-based study of the onset, progression, and course of heart disease and stroke in the elderly which began in 1988. We are only examining those that participated in the the CHS All Stars which is from the same cohort of people who were still alive in 2005 when enrollment began. We approached everyone who was in the CHS study and asked them to participate in the CHS All Stars study. Blood samples were collected at the year 18 visit and analyzed for serum 25(OH)D.

Description

Inclusion Criteria:

  • Participant in the main CHS study

Exclusion Criteria:

  • Not willing to give consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
At the year 18 visit of the CHS study
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
Years 18 - 21 of CHS Study

Secondary Outcome Measures

Outcome Measure
Time Frame
To describe the prevalence and correlates of vitamin D insufficiency in adults of advanced age.
Time Frame: Year 18 of CHS study
Year 18 of CHS study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (ACTUAL)

February 1, 2011

Study Completion (ACTUAL)

February 1, 2011

Study Registration Dates

First Submitted

July 2, 2008

First Submitted That Met QC Criteria

July 2, 2008

First Posted (ESTIMATE)

July 8, 2008

Study Record Updates

Last Update Posted (ACTUAL)

July 6, 2018

Last Update Submitted That Met QC Criteria

July 3, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

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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