Expired Study
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Winston-Salem, North Carolina 27157


Purpose:

A growing body of evidence suggests that vitamin D status is important in biologic processes involved in the maintenance of physical function. To advance the investigators understanding of the role of vitamin D in physical function, the investigators will conduct a feasibility pilot study to collect key information to help design a full-scale randomized trial to determine whether vitamin D supplementation will delay declines in physical function. The primary goals of the pilot study are to determine cost-effective strategies for identifying persons at high risk for functional decline with insufficient vitamin D levels, determine the serum vitamin D response to a vitamin D supplementation regimen designed to attain sufficient vitamin D levels, and provide preliminary data of key functional measures (balance, physical performance and muscle power) for the future larger study design. A secondary goal is to begin to examine potential mechanisms by which vitamin D supplementation may enhance physical performance by exploring the effects of vitamin D supplementation on changes in skeletal muscle gene expression.


Study summary:

A growing body of evidence suggests that vitamin D status is important in biologic processes involved in the maintenance of physical function. However, whether remediation of vitamin D insufficiency will improve physical function and the potential mechanisms involved are unclear. Previous vitamin D supplementation trials have produced mixed results with respect to physical function; however, most trials did not specifically recruit individuals who were vitamin D insufficient nor is the potential mechanism of action understood well enough to appropriately select those individuals most likely to benefit. To advance our understanding of the role of vitamin D in physical function, the investigators will conduct a feasibility pilot study to collect key information to help design a full-scale randomized trial to determine whether vitamin D supplementation will delay declines in physical function. The primary goals of the pilot study are to determine cost-effective strategies for identifying persons at high risk for functional decline with insufficient vitamin D levels, determine the serum vitamin D response to a vitamin D supplementation regimen designed to attain sufficient vitamin D levels, and provide preliminary data of key functional measures (balance, short physical performance battery (SBBP) and muscle power) for the future larger study design. A secondary goal is to begin to examine potential mechanisms by which vitamin D supplementation may enhance physical performance and muscle contractility by exploring the effects of vitamin D supplementation on changes in skeletal muscle gene expression using microarrays.


Criteria:

Inclusion Criteria: - Short Physical Performance Battery (SPPB) score of ≥ 4 to < 10 - Vitamin D insufficient (serum 25(OH)D ≥ 10 to < 25 ng/mL) Exclusion Criteria: - Serious or uncontrolled chronic disease including: insulin-dependent or uncontrolled diabetes; cancer requiring treatment in past year, except non-melanoma skin cancers; past or current ischemic heart disease, uncontrolled angina, heart failure, peripheral artery disease (PAD), or stroke; chronic respiratory disease; uncontrolled endocrine/metabolic disease; neurological or hematological disease; liver or renal dysfunction; and severe musculoskeletal impairment - Impaired cognitive function (MMSE ≤ 24) - Dependent on a cane or walker - Use of anti-coagulants - Unwillingness to undergo a muscle biopsy - Taking prescription vitamin D2 or OCT vitamin D3 supplements of > 1000 IU/d - Inability or contraindications to consume daily vitamin D and calcium supplements - Weight loss of ≥ 5% or more in the past 6 months - Involved in any other intervention


Study is Available At:


Original ID:

IRB00011371


NCT ID:

NCT01179503


Secondary ID:

R01AG029364-03S1


Study Acronym:


Brief Title:

Vitamin D Supplementation and Physical Function in Older Adults


Official Title:

Vitamin D Supplementation, Skeletal Muscle Gene Expression, and Physical Performance in Older Adults


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

70 Years


Maximum Age:

89 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Wake Forest University Health Sciences


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

16


Enrollment Type:

Actual


Overall Contact Information

Official Name:Denise K Houston, PhD
Study Director
Wake Forest University

Study Dates

Start Date:January 2010
Completion Date:May 2011
Completion Type:Actual
Primary Completion Date:May 2011
Primary Completion Type:Actual
Verification Date:August 2018
Last Changed Date:August 15, 2018
First Received Date:August 10, 2010

Study Outcomes

Outcome Type:Primary Outcome
Measure:Change in Physical performance
Time Frame:4 months
Safety Issues:False
Description:Change in the expanded Short Physical Performance Battery (SPPB) score (composite score including the following: timed 4m walk; time to stand from a chair 5 times without the use of arms; and time to hold side-by-side, semi-tandem, tandem, and one legged
Outcome Type:Secondary Outcome
Measure:Skeletal muscle gene expression
Time Frame:4 months
Safety Issues:False
Description:Muscle will be obtained from the vastus lateralis using the percutaneous needle biopsy technique. Five µg of RNA will be supplied for each experimental condition to be analyzed. The WFUHS MicroArray Core Facility further purifies the provided RNA over an
Outcome Type:Secondary Outcome
Measure:Change in expanded SPPB balance task time
Time Frame:4 months
Safety Issues:False
Description:Change in expanded SPPB balance task time (time to hold side-by-side, semi-tandem, tandem, and one legged stands; max of 30 sec)
Outcome Type:Secondary Outcome
Measure:Change in narrow 4m walk test of balance time
Time Frame:4 months
Safety Issues:False
Description:Change in time to complete narrow 4m walk test of balance (usual pace over 4m while staying between lines of colored tape placed 20cm apart)
Outcome Type:Secondary Outcome
Measure:Change in 400m walk test time
Time Frame:4 months
Safety Issues:False
Description:Change in 400m walk test time (usual pace)
Outcome Type:Secondary Outcome
Measure:Change in knee extensor power
Time Frame:4 months
Safety Issues:False
Description:Change in knee extensor power measured by the Nottingham Power Rig

Study Interventions

Intervention Type:Dietary Supplement
Name:Vitamin D plus calcium
Description:1000 IU of vitamin D3 twice daily (for a total of 2000 IU/day) plus 600 mg calcium carbonate twice daily (for a total of 1200 mg/day)
Arm Name:Vitamin D plus calcium
Intervention Type:Dietary Supplement
Name:calcium
Description:600 mg calcium carbonate twice daily (total of 1200 mg/day) for 4 months
Arm Name:Calcium only

Study Arms

Study Arm Type:Active Comparator
Arm Name:Calcium only
Description:1200 mg Calcium per day
Study Arm Type:Experimental
Arm Name:Vitamin D plus calcium
Description:2000 IU vitamin D plus 1200 mg calcium per day

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Wake Forest University Health Sciences
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institute on Aging (NIA)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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