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临床试验/NCT03019120
NCT03019120撤回2 期

The Effect of Vitamin D Supplementation on Neurocognitive Function in Older Subjects

Rambam Health Care Campus1 个研究点 分布在 1 个国家开始时间: 2017年1月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
撤回
试验地点
1
主要终点
Change in cognitive function as assessed by the Neurotrax computerized cognitive assessment battery

研究概览

简要总结

This study will evaluate the effect of vitamin D supplementation on the neurocognitive function of older people with lower than normal levels of vitamin D at baseline

详细描述

Background: Ageing is associated with an increased risk of cognitive decline. Vitamin D plays an important role in many of the symptoms and conditions related to advanced age, including impaired balance, falls and osteoporosis. Vitamin D also has a physiological effect on the function of the central nervous system, and studies have suggested a relationship between this vitamin and changes in cognitive function of older people. The investigators propose a pilot study to evaluate the effect of vitamin D supplementation on the neurocognitive function of older people.

Methods: A total of 30 subjects of both genders older than 65 years with levels of 25-OH Vitamin D lower than 30 ng/ml on routine laboratory screening will be included in the study. Exclusion criteria will include any unstable medical condition as determined by the treating physician, a diagnosis of dementia, the use of supplements containing vitamin D in any dose, significant visual or hearing impairment not corrected by spectacles or hearing aids, and a level of literacy that limits the performance of computerized neurocognitive testing. Following provision of written informed consent for inclusion in the study, subjects will answer a questionnaire providing demographic details, undergo cognitive screening by use of the MoCA test, and computerized cognitive assessment using the Neurotrax battery. All subjects will undergo repeat testing for level of 25-OH Vitamin D, and where below-normal levels are confirmed patients will receive a supplemental monthly oral dose of 60000 units Vitamin D administered by a nurse for a period of 3 months. Levels of serum calcium will be repeated monthly (end of month 1, 2, 3). At 3 months subjects will undergo repeat testing for level of 25-OH Vitamin D, and repeat computerized cognitive assessment using the Neurotrax battery.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Adults aged 65 years and older.
  • Level of vitamin D (25-OH vitamin D) is less than 30 ng / ml.
  • Stable health status as assessed by the treating primary care physician.
  • Do not take supplements containing vitamin D.
  • Normal cognitive function as determined by MoCA Test screening and clinical assessment
  • Adequate literacy to enable the performance of cognitive assessment instruments
  • Provide informed consent as required by the Ethics Committee.

排除标准

  • Age younger than 65 years
  • Health status not stable as determined by the treating primary care physician
  • A diagnosis of dementia
  • Taking supplements containing Vitamin D
  • Significant visual or hearing impairment not corrected by spectacles or hearing aids
  • Impaired competency limiting the subject's ability to provide informed consent

研究组 & 干预措施

Active Comparator: Intervention group

Experimental

Vitamin D supplementation for subjects with below normal levels of this vitamin.

干预措施: Vitamin D (Drug)

结局指标

主要结局

Change in cognitive function as assessed by the Neurotrax computerized cognitive assessment battery

时间窗: 3 months

The Neurotrax computerized cognitive assessment instrument measures the following domains: Memory, executive functions, attention, verbal functions and motor skills. This instrument was found to have high validity in identifying patients who suffer from cognitive decline in comparison to healthy patients in the elderly. There are many advantages to a computerized cognitive assessment tool. It allows a measurement of various cognitive domains as well as an accurate, detailed and objective measurements of patients. It is also very sensitive to cognitive changes occurring in a specific individual over time.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tzvi Dwolatzky

Prof.

Rambam Health Care Campus

研究点 (1)

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