Vitamin D Supplementation, Skeletal Muscle Gene Expression, and Physical Performance in Older Adults
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Change in Physical performance
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 70 Years 至 89 Years(Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Short Physical Performance Battery (SPPB) score of ≥ 4 to < 10
- •Vitamin D insufficient (serum 25(OH)D ≥ 10 to < 25 ng/mL)
排除标准
- •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
研究组 & 干预措施
Calcium only
1200 mg Calcium per day
干预措施: calcium (Dietary Supplement)
Vitamin D plus calcium
2000 IU vitamin D plus 1200 mg calcium per day
干预措施: Vitamin D plus calcium (Dietary Supplement)
结局指标
主要结局
Change in Physical performance
时间窗: 4 months
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)
次要结局
- Skeletal muscle gene expression(4 months)
- Change in expanded SPPB balance task time(4 months)
- Change in narrow 4m walk test of balance time(4 months)
- Change in 400m walk test time(4 months)
- Change in knee extensor power(4 months)
