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OpenTrials
Completed

NCT Number: NCT00710957

Vitamin D and Physical Function in Older Adults

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.

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Key information

Age range

79 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participant in the main CHS study

Exclusion criteria

  • Not willing to give consent

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. To describe the prevalence and correlates of vitamin D insufficiency in adults of advanced age.

    Time frame: Year 18 of CHS study

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

Role of Vitamin D Status on Physical Function and Falls in Adults of Advanced Age

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Jul 8, 2008
Registry last updated
Jul 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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