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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000090463', 'term': 'Iron Deficiencies'}], 'ancestors': [{'id': 'D019189', 'term': 'Iron Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2021-10-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-10', 'studyFirstSubmitDate': '2016-12-09', 'studyFirstSubmitQcDate': '2016-12-09', 'lastUpdatePostDateStruct': {'date': '2024-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-10-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in mean iron content in specific brain nuclei', 'timeFrame': 'Up to 5 months', 'description': "To assess the iron deposition/accumulation in subjects' brain region by using neuroimaging such as MRI/fMRI."}, {'measure': 'Cognition Fluid Composite Score', 'timeFrame': 'Up to 5 months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Activity and connectivity in specific functional networks at resting state', 'timeFrame': 'Up to 5 months', 'description': '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.'}, {'measure': 'Brain activity during tasks of processing speed and episodic memory', 'timeFrame': 'Up to 5 months', 'description': '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.'}, {'measure': 'NIH Toolbox Auditory Verbal Learning Test (Rey) Score', 'timeFrame': 'Up to 5 months', 'description': '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.'}, {'measure': 'NIH Toolbox Flanker Inhibitory Control and Attention Test Score', 'timeFrame': 'Up to 5 months', 'description': '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.'}, {'measure': 'NIH Toolbox List Sorting Working Memory Test Score', 'timeFrame': 'Up to 5 months', 'description': '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.'}, {'measure': 'NIH Toolbox Dimensional Change Card Sort Test', 'timeFrame': 'Up to 5 months', 'description': '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.'}, {'measure': 'NIH Toolbox Pattern Comparison Processing Speed Test Score', 'timeFrame': 'Up to 5 months', 'description': '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.'}, {'measure': 'NIH Toolbox Picture Sequence Memory Test', 'timeFrame': 'Up to 5 months', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Iron repletion', 'Blood donation', 'Transfusion'], 'conditions': ['Iron Deficiency']}, 'referencesModule': {'references': [{'pmid': '23874300', 'type': 'BACKGROUND', 'citation': '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': '23829880', 'type': 'BACKGROUND', 'citation': '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': '25469720', 'type': 'BACKGROUND', 'citation': "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': '22023513', 'type': 'BACKGROUND', 'citation': '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': '21388389', 'type': 'BACKGROUND', 'citation': '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': '17002622', 'type': 'BACKGROUND', 'citation': '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': '41118254', 'type': 'DERIVED', 'citation': '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:e194442. doi: 10.1172/jci.insight.194442. Online ahead of print.'}, {'pmid': '36069596', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Current participant of the associated randomized controlled trial conducted at Columbia University Medical Center (therefore invited to participate in this optional ancillary study).\n\nExclusion Criteria:\n\n* Not a current participant of the associated randomized controlled trial conducted at Columbia University Medical Center.'}, 'identificationModule': {'nctId': 'NCT02990559', 'briefTitle': 'Neuroimaging of Donor Iron Deficient Study', 'organization': {'class': 'OTHER', 'fullName': 'Columbia University'}, 'officialTitle': 'Neuroimaging of Donor Iron Deficient Study (DIDS)', 'orgStudyIdInfo': {'id': 'AAAR0145'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Iron Repletion', 'description': '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.'}, {'label': 'Placebo', 'description': 'Subjects participating in the associated study under the Placebo arm will also undergo MRI/fMRI scans on two occasions, while performing cognitive tasks.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10023', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Irving Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Eldad Hod, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Associate Professor of Pathology and Cell Biology, Dept of Pathology&Cell Biology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Columbia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Pathology and Cell Biology, Dept of Pathology&Cell Biology', 'investigatorFullName': 'Eldad Arie Hod', 'investigatorAffiliation': 'Columbia University'}}}}