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临床试验/NCT01170273
NCT01170273已完成3 期

Vitamin D in Vulnerable Adults

VA Office of Research and Development2 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2010年8月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
130
试验地点
2
主要终点
Change in Short Physical Performance Battery Test Score

研究概览

简要总结

Vitamin D insufficiency is a problem of growing concern, given its prevalence in older persons and the association of low vitamin D with multiple major health problems, including mobility and balance deterioration and falls, cardiovascular disease, diabetes, and certain cancers. Sedentary persons are particularly vulnerable for these health problems and generally not adherent to prescribed physical activity. This study will investigate if treatment with vitamin D will benefit physical performance in male veterans age 65 to 95.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
65 Years 至 95 Years(Older Adult)
性别
Male
接受健康志愿者

入选标准

  • male veterans
  • 65 to 95 years of age
  • independent
  • sedentary
  • vitamin D insufficiency

排除标准

  • hypercalcemia
  • renal failure
  • living in a nursing home

结局指标

主要结局

Change in Short Physical Performance Battery Test Score

时间窗: baseline and 9 months

The short physical performance battery (SPPB) examines 3 areas of lower extremity function: static balance test, gait speed test and getting in and out of a chair test. The total SPPB score is the sum of the scores of the 3 components and can range from 0 to 12, with 0 reflecting severe limitations and 12 minimal or no limitations. The ranges for each subscale are: balance (0-4), gait speed (0-4), sit-to-stand (0-4). In all the subscales, 0 reflects worse outcome and 4 best outcome.

次要结局

未报告次要终点

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (2)

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