Neuroimaging of Donor Iron Deficient Study (DIDS)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Columbia University
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- Change in mean iron content in specific brain nuclei
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Current participant of the associated randomized controlled trial conducted at Columbia University Medical Center (therefore invited to participate in this optional ancillary study).
Exclusion Criteria
- •Not a current participant of the associated randomized controlled trial conducted at Columbia University Medical Center.
Outcomes
Primary Outcomes
Change in mean iron content in specific brain nuclei
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- 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)
Investigators
Eldad Arie Hod
Associate Professor of Pathology and Cell Biology, Dept of Pathology&Cell Biology
Columbia University