NCT02990559

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 9, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 13, 2016

Completed
19 days until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 4, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 4, 2021

Completed
Last Updated

June 12, 2024

Status Verified

June 1, 2024

Enrollment Period

4.8 years

First QC Date

December 9, 2016

Last Update Submit

June 10, 2024

Conditions

Iron Deficiency

Keywords

Iron repletionBlood donationTransfusion

Outcome Measures

Primary Outcomes (2)

  • 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.

    Up to 5 months

  • 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.

    Up to 5 months

Secondary Outcomes (8)

  • 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 Auditory Verbal Learning Test (Rey) Score

    Up to 5 months

  • NIH Toolbox Flanker Inhibitory Control and Attention Test Score

    Up to 5 months

  • NIH Toolbox List Sorting Working Memory Test Score

    Up to 5 months

  • +3 more secondary outcomes

Study Arms (2)

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.

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10023, United States

Location

Related Publications (8)

  • 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.

    PMID: 23874300BACKGROUND

  • 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.

    PMID: 23829880BACKGROUND

  • 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.

    PMID: 25469720BACKGROUND

  • 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.

    PMID: 22023513BACKGROUND

  • 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.

    PMID: 21388389BACKGROUND

  • 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.

    PMID: 17002622BACKGROUND

  • 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.

    PMID: 41118254DERIVED

  • 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.

    PMID: 36069596DERIVED

MeSH Terms

Conditions

Iron Deficiencies

Condition Hierarchy (Ancestors)

Iron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Eldad Hod, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Pathology and Cell Biology, Dept of Pathology&Cell Biology

Study Record Dates

First Submitted

December 9, 2016

First Posted

December 13, 2016

Study Start

January 1, 2017

Primary Completion

October 4, 2021

Study Completion

October 4, 2021

Last Updated

June 12, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)