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Iron DeficiencyNCT02990559

Neuroimaging of Donor Iron Deficient Study

An observational study of Iron Deficiency, run by Columbia University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Iron Deficiency
How many people
75 participants
Where
1 siteUnited States
Study dates
Jan 2017to 4 Oct 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Columbia University Irving Medical Center

    New York, New York, 10023

Other trials in United States

About this study

Official title: Neuroimaging of Donor Iron Deficient Study (DIDS)

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.

Read the 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.

Conditions
Iron Deficiency
Keywords
Iron repletion, Blood donation, Transfusion
Medical subject headings
Iron Deficiencies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02990559
Study groupRoleWhat they receive
Iron RepletionSubjects 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.
PlaceboSubjects participating in the associated study under the Placebo arm will also undergo MRI/fMRI scans on two occasions, while performing cognitive tasks.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in mean iron content in specific brain nuclei

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

    Measured: Up to 5 months

  2. Cognition Fluid Composite Score

    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.

    Measured: Up to 5 months

Secondary outcomes (8)

  1. Activity and connectivity in specific functional networks at resting state

    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.

    Measured: Up to 5 months

  2. Brain activity during tasks of processing speed and episodic memory

    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.

    Measured: Up to 5 months

  3. NIH Toolbox Auditory Verbal Learning Test (Rey) Score

    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.

    Measured: Up to 5 months

  4. NIH Toolbox Flanker Inhibitory Control and Attention Test Score

    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.

    Measured: Up to 5 months

  5. NIH Toolbox List Sorting Working Memory Test Score

    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.

    Measured: Up to 5 months

  6. NIH Toolbox Dimensional Change Card Sort Test

    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.

    Measured: Up to 5 months

  7. NIH Toolbox Pattern Comparison Processing Speed Test Score

    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.

    Measured: Up to 5 months

  8. NIH Toolbox Picture Sequence Memory Test

    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.

    Measured: Up to 5 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2016 (estimated)
  2. Study startJan 2017
  3. Primary completion4 Oct 2021
  4. Study completion4 Oct 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02990559
Sponsor's protocol ID
AAAR0145
Status last verified
Jun 2024
First submitted
9 Dec 2016
Last updated
12 Jun 2024
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Hare D, Ayton S, Bush A, Lei P. A delicate balance: Iron metabolism and diseases of the brain. Front Aging Neurosci. 2013 Jul 18;5:34. doi: 10.3389/fnagi.2013.00034. eCollection 2013.

    PubMed 23874300

  • Smith GA, Fisher SA, Doree C, Roberts DJ. A systematic review of factors associated with the deferral of donors failing to meet low haemoglobin thresholds. Transfus Med. 2013 Oct;23(5):309-20. doi: 10.1111/tme.12046. Epub 2013 Jul 5.

    PubMed 23829880

  • Bialkowski W, Bryant BJ, Schlumpf KS, Wright DJ, Birch R, Kiss JE, D'Andrea P, Cable RG, Spencer BR, Vij V, Mast AE. The strategies to reduce iron deficiency in blood donors randomized trial: design, enrolment and early retention. Vox Sang. 2015 Feb;108(2):178-85. doi: 10.1111/vox.12210. Epub 2014 Dec 3.

    PubMed 25469720

  • Cable RG, Glynn SA, Kiss JE, Mast AE, Steele WR, Murphy EL, Wright DJ, Sacher RA, Gottschall JL, Tobler LH, Simon TL; NHLBI Retrovirus Epidemiology Donor Study-II (REDS-II). Iron deficiency in blood donors: the REDS-II Donor Iron Status Evaluation (RISE) study. Transfusion. 2012 Apr;52(4):702-11. doi: 10.1111/j.1537-2995.2011.03401.x. Epub 2011 Oct 24.

    PubMed 22023513

  • Brittenham GM. Iron deficiency in whole blood donors. Transfusion. 2011 Mar;51(3):458-61. doi: 10.1111/j.1537-2995.2011.03062.x. No abstract available.

    PubMed 21388389

  • Newman B. Iron depletion by whole-blood donation harms menstruating females: the current whole-blood-collection paradigm needs to be changed. Transfusion. 2006 Oct;46(10):1667-81. doi: 10.1111/j.1537-2995.2006.00969.x. No abstract available.

    PubMed 17002622

  • Hod EA, Habeck C, Zhuang H, Dimov A, Spincemaille P, Kessler D, Bitan ZC, Feit Y, Fliginger D, Stone EF, Roh D, Eisler L, Dashnaw S, Caccappolo E, McMahon DJ, Stern Y, Wang Y, Spitalnik SL, Brittenham GM. Effects of iron repletion on brain iron content, myelination, neural network activation, and cognition. JCI Insight. 2025 Oct 21;10(23):e194442. doi: 10.1172/jci.insight.194442. eCollection 2025 Dec 8.

    PubMed 41118254

  • Hod EA, Brittenham GM, Bitan ZC, Feit Y, Gaelen JI, La Carpia F, Sandoval LA, Zhou AT, Soffing M, Mintz A, Schwartz J, Eng C, Scotto M, Caccappolo E, Habeck C, Stern Y, McMahon DJ, Kessler DA, Shaz BH, Francis RO, Spitalnik SL. A randomized trial of blood donor iron repletion on red cell quality for transfusion and donor cognition and well-being. Blood. 2022 Dec 22;140(25):2730-2739. doi: 10.1182/blood.2022017288.

    PubMed 36069596

Questions about this trial

What is this clinical trial studying?

An observational study of Iron Deficiency, run by Columbia University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in mean iron content in specific brain nuclei (time frame: Up to 5 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02990559, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2024.

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