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Neuroimaging of Donor Iron Deficient Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02990559
Recruitment Status : Enrolling by invitation
First Posted : December 13, 2016
Last Update Posted : March 27, 2019
Sponsor:
Information provided by (Responsible Party):
Eldad Arie Hod, Columbia University

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.

Condition or disease
Iron Deficiency

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.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Neuroimaging of Donor Iron Deficient Study (DIDS)
Actual Study Start Date : January 2017
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

Group/Cohort
Iron Repletion
Subjects participating in the associated study under the Iron Repletion arm will also undergo MRI (Magnetic Resonance Imaging) scan/fMRI (functional Magnetic Resonance Imaging) scan on two occasions, while performing cognitive tasks.
Placebo
Subjects participating in the associated study under the Placebo arm will also undergo MRI/fMRI scans on two occasions, while performing cognitive tasks.



Primary Outcome Measures :
  1. 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.

  2. 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 Outcome Measures :
  1. Activity and connectivity in specific functional networks at resting state [ Time Frame: Up to 5 months ]
    Resting state blood oxygen level dependent (BOLD) signals will be assessed by fMRI. Independent component analysis will be used to detect alterations in connectivity in functional networks (e.g., default mode network and visual, sensory/motor, executive control, temporal/parietal, basal ganglia components) in a paired analysis comparing subjects before and after iron repletion versus placebo.

  2. Brain activity during tasks of processing speed and episodic memory [ Time Frame: Up to 5 months ]
    Brain activity patterns during performance of processing speed and episodic memory tasks will be assessed by fMRI and comparisons made from before to after iron repletion versus placebo.

  3. NIH Toolbox Auditory Verbal Learning Test (Rey) Score [ Time Frame: Up to 5 months ]
    NIH Toolbox derived uncorrected standard Auditory Verbal Learning test score, measured at 4 time points (twice pre-randomization and twice post-randomization). Delayed and initial scores analyzed separately. The raw score will be used in which a higher number represents more words remembered.

  4. NIH Toolbox Flanker Inhibitory Control and Attention Test Score [ Time Frame: Up to 5 months ]
    NIH Toolbox derived uncorrected standard Flanker Inhibitory Control and Attention test score (single 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.

  5. NIH Toolbox List Sorting Working Memory Test Score [ Time Frame: Up to 5 months ]
    NIH Toolbox derived uncorrected standard List Sorting Working Memory test 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.

  6. NIH Toolbox Dimensional Change Card Sort Test [ Time Frame: Up to 5 months ]
    NIH Toolbox derived uncorrected standard Dimensional Change Card Sort test 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.

  7. NIH Toolbox Pattern Comparison Processing Speed Test Score [ Time Frame: Up to 5 months ]
    NIH Toolbox derived uncorrected standard Pattern Comparison Processing Speed test 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.

  8. NIH Toolbox Picture Sequence Memory Test [ Time Frame: Up to 5 months ]
    NIH Toolbox derived uncorrected standard Picture Sequence Memory test 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects with iron deficiency from blood donation will be recruited over 5 years in the associated randomized controlled trial conducted at Columbia University Medical Center.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02990559


Locations
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United States, New York
Columbia University Medical Center
New York, New York, United States, 10023
Sponsors and Collaborators
Columbia University
Investigators
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Principal Investigator: Eldad Hod, MD Associate Professor of Pathology and Cell Biology, Dept of Pathology&Cell Biology
Publications:
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Responsible Party: Eldad Arie Hod, Associate Professor of Pathology and Cell Biology, Dept of Pathology&Cell Biology, Columbia University
ClinicalTrials.gov Identifier: NCT02990559    
Other Study ID Numbers: AAAR0145
First Posted: December 13, 2016    Key Record Dates
Last Update Posted: March 27, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Eldad Arie Hod, Columbia University:
Iron repletion
Blood donation
Transfusion
Additional relevant MeSH terms:
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Anemia, Iron-Deficiency
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases