Vitamin D Supplementation and Physical Function in Older Adults

Completed · Early Phase 1

Conditions studied: Physical Function, Vitamin D Insufficiency

In brief

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.

Key facts

Study ID

NCT01179503

Run by

Wake Forest University Health Sciences

People needed

16

Starts

2010-01-01

Expected to finish

2011-05-01

Last updated by the study team

2018-08-17

Who can join

Age: 70 and older, up to 89. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Short Physical Performance Battery (SPPB) score of ≥ 4 to < 10
• Vitamin D insufficient (serum 25(OH)D ≥ 10 to < 25 ng/mL)

You may not qualify if…

• 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

Where it is running

• Wake Forest University — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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