Ignite Creation Date:
2025-12-24 @ 2:40 PM
Ignite Modification Date:
2026-02-05 @ 4:36 AM
Study NCT ID:
NCT02990559
Status:
COMPLETED
Last Update Posted:
2024-06-12
First Post:
2016-12-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neuroimaging of Donor Iron Deficient Study
Sponsor:
Columbia University
Organization:
Study Overview
Official Title:
Neuroimaging of Donor Iron Deficient Study (DIDS)
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: