NCT01179503

Vitamin D Supplementation and Physical Function in Older Adults

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 70 Years – 89 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Physical Function
• Vitamin D Insufficiency

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	calcium	600 mg calcium carbonate twice daily (total of 1200 mg/day) for 4 months
DIETARY_SUPPLEMENT	Vitamin D plus calcium	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)

Timeline

• Start date: 2010-01-01
• Primary completion: 2011-05-01
• Completion: 2011-05-01
• First posted: 2010-08-11
• Last updated: 2018-08-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study