Vitamin D and Physical Function in Older Adults

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Denise K. Houston, PhD, RD, Wake Forest School of Medicine
ClinicalTrials.gov Identifier:
NCT00710957
First received: July 2, 2008
Last updated: November 14, 2013
Last verified: November 2013
  Purpose

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.


Condition
Vitamin D
Physical Function

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Role of Vitamin D Status on Physical Function and Falls in Adults of Advanced Age

Resource links provided by NLM:


Further study details as provided by Wake Forest School of Medicine:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To describe the prevalence and correlates of vitamin D insufficiency in adults of advanced age. [ Time Frame: Year 18 of CHS study ] [ Designated as safety issue: No ]

Enrollment: 1100
Study Start Date: April 2008
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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).

  Eligibility

Ages Eligible for Study:   79 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

Inclusion Criteria:

  • Participant in the main CHS study

Exclusion Criteria:

  • Not willing to give consent
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00710957

Sponsors and Collaborators
Wake Forest School of Medicine
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Denise Houston, PhD Wake Forest School of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Denise K. Houston, PhD, RD, Associate Professor, Wake Forest School of Medicine
ClinicalTrials.gov Identifier: NCT00710957     History of Changes
Other Study ID Numbers: Merck - 33500
Study First Received: July 2, 2008
Last Updated: November 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Wake Forest School of Medicine:
Vitamin D
Physical Function
Falls
Aging
CHS

Additional relevant MeSH terms:
Ergocalciferols
Vitamin D
Vitamins
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 20, 2014