Vitamin D and Physical Function in Older Adults

NCT ID: NCT00710957

Last Updated: 2018-07-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2011-02-28

Brief Summary

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.

Conditions

Vitamin D; Physical Function

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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).

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Participant in the main CHS study

Exclusion Criteria

• Not willing to give consent

• Minimum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Denise Houston, PhD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Other Identifiers

IRB00005739

Identifier Type: -

Identifier Source: org_study_id