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临床试验/NCT01179503
NCT01179503已完成早期 1 期

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

Wake Forest University Health Sciences2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2010年1月最近更新:
适应症
干预措施

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

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

Active Comparator

1200 mg Calcium per day

干预措施: calcium (Dietary Supplement)

Vitamin D plus calcium

Experimental

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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