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临床试验/NCT02990559
NCT02990559已完成不适用

Neuroimaging of Donor Iron Deficient Study (DIDS)

Columbia University1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2017年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
75
试验地点
1
主要终点
Change in mean iron content in specific brain nuclei

研究概览

简要总结

This pilot study is designed to investigate (1) whether getting iron treatment affects iron in the brain and (2) how getting iron treatment affects brain functions when it is performing specific cognitive tasks. By cognitive tasks, it means tasks that involve perceiving, representing, or assessing things. The specific cognitive tasks used here will involve tests of memory and processing speed.

详细描述

Iron, the most abundant metal in the brain, is vital for multiple cellular processes, including neurotransmitter synthesis, neuron myelination, and mitochondrial function. In the United States, of the donors who provided the ~15 million units of red blood cells that were collected for transfusion, 69% were repeat donors. Although iron deficiency is surprisingly prevalent in first-time donors, its prevalence is even higher in these particularly altruistic frequent donors, (i.e., up to 49% and 66% of male and female repeat donors, respectively), manifested as iron depletion or iron-deficient erythropoiesis. Iron deficiency from blood donation is associated with fatigue, restless leg syndrome, decreased physical endurance and work capacity, and impaired concentration, attention, and other neurocognitive functions; however, these conclusions are not based on definitive studies and have not yet changed blood donation policy. This study is to collect data through noninvasive procedures routinely employed in clinical practice to better understand how iron treatment may affect brain functions.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Current participant of the associated randomized controlled trial conducted at Columbia University Medical Center (therefore invited to participate in this optional ancillary study).

排除标准

  • Not a current participant of the associated randomized controlled trial conducted at Columbia University Medical Center.

结局指标

主要结局

Change in mean iron content in specific brain nuclei

时间窗: Up to 5 months

To assess the iron deposition/accumulation in subjects' brain region by using neuroimaging such as MRI/fMRI.

Cognition Fluid Composite Score

时间窗: Up to 5 months

NIH Toolbox derived uncorrected standard composite score, measured at 4 time points (twice pre-randomization and twice post-randomization). The uncorrected standard score will be used, where the normative mean is 100 with a standard deviation of 15.

次要结局

  • Activity and connectivity in specific functional networks at resting state(Up to 5 months)
  • Brain activity during tasks of processing speed and episodic memory(Up to 5 months)
  • NIH Toolbox Dimensional Change Card Sort Test(Up to 5 months)
  • NIH Toolbox Auditory Verbal Learning Test (Rey) Score(Up to 5 months)
  • NIH Toolbox List Sorting Working Memory Test Score(Up to 5 months)
  • NIH Toolbox Pattern Comparison Processing Speed Test Score(Up to 5 months)
  • NIH Toolbox Flanker Inhibitory Control and Attention Test Score(Up to 5 months)
  • NIH Toolbox Picture Sequence Memory Test(Up to 5 months)

研究者

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

Eldad Arie Hod

Associate Professor of Pathology and Cell Biology, Dept of Pathology&Cell Biology

Columbia University

研究点 (1)

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Neuroimaging of Donor Iron Deficient Study | 临床试验