Clinical trial NCT01179503: Vitamin D Supplementation and Physical Function in Older Adults
Official title: Vitamin D Supplementation, Skeletal Muscle Gene Expression, and Physical Performance in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Physical Function
Vitamin D Insufficiency
Keywords: vitamin D
physical performance
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2010-08-11
Enrollment: 16
Sex: ALL
Minimum age (years): 70
Maximum age (years): 89
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility 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

Primary outcomes:
measure: Change in Physical performance
timeFrame: 4 months
Secondary outcomes:
measure: Skeletal muscle gene expression
timeFrame: 4 months
measure: Change in expanded SPPB balance task time
timeFrame: 4 months
measure: Change in narrow 4m walk test of balance time
timeFrame: 4 months
measure: Change in 400m walk test time
timeFrame: 4 months
measure: Change in knee extensor power
timeFrame: 4 months
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University
state: North Carolina
Study officials:
affiliation: Wake Forest University
name: Denise K Houston, PhD
role: STUDY_DIRECTOR
affiliation: Wake Forest University Health Sciences
name: Stephen B Kritchevsky, PhD
role: PRINCIPAL_INVESTIGATOR
References: