Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2025-12-29 @ 4:04 AM
Study NCT ID:
NCT00710957
Status:
COMPLETED
Last Update Posted:
2018-07-06
First Post:
2008-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vitamin D and Physical Function in Older Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-03', 'studyFirstSubmitDate': '2008-07-02', 'studyFirstSubmitQcDate': '2008-07-02', 'lastUpdatePostDateStruct': {'date': '2018-07-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-07-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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.', 'timeFrame': 'At the year 18 visit of the CHS study'}, {'measure': '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.', 'timeFrame': 'Years 18 - 21 of CHS Study'}], 'secondaryOutcomes': [{'measure': 'To describe the prevalence and correlates of vitamin D insufficiency in adults of advanced age.', 'timeFrame': 'Year 18 of CHS study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Vitamin D', 'Physical Function', 'Falls', 'Aging', 'CHS'], 'conditions': ['Vitamin D', 'Physical Function']}, 'descriptionModule': {'briefSummary': '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:\n\nSpecific Aim 1. To describe the prevalence and correlates of vitamin D insufficiency in adults of advanced age.\n\nSpecific 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.\n\nSpecific 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.\n\nResearch 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '79 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant in the main CHS study\n\nExclusion Criteria:\n\n* Not willing to give consent'}, 'identificationModule': {'nctId': 'NCT00710957', 'briefTitle': 'Vitamin D and Physical Function in Older Adults', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Role of Vitamin D Status on Physical Function and Falls in Adults of Advanced Age', 'orgStudyIdInfo': {'id': 'IRB00005739'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CHS All Stars', 'description': '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).'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Denise Houston, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}