An Early Phase 1 interventional study of calcium and Vitamin D plus calcium in Physical Function and Vitamin D Insufficiency, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 70 Years to 89 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-17.
Sponsored by Wake Forest University Health Sciences · Early Phase 1, Interventional, and Treatment
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.
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.
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Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.
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Exclusion Criteria:
1200 mg Calcium per day
Dietary Supplement: calcium
2000 IU vitamin D plus 1200 mg calcium per day
Dietary Supplement: Vitamin D plus calcium
600 mg calcium carbonate twice daily (total of 1200 mg/day) for 4 months
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)
Change in Physical performance
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 stands for the testing of balance)
Time frame: 4 months
Skeletal muscle gene expression
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 RNAeasy column and performs all subsequent steps of the GeneChip protocol (cDNA generation, generation of biotinylated cRNA, chip hybridization, and generation of .CEL files).
Time frame: 4 months
Change in expanded SPPB balance task time
Change in expanded SPPB balance task time (time to hold side-by-side, semi-tandem, tandem, and one legged stands; max of 30 sec)
Time frame: 4 months
Change in narrow 4m walk test of balance time
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)
Time frame: 4 months
Change in 400m walk test time
Change in 400m walk test time (usual pace)
Time frame: 4 months
Change in knee extensor power
Change in knee extensor power measured by the Nottingham Power Rig
Time frame: 4 months
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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Wake Forest University Health Sciences