Neuroimaging of Donor Iron Deficient Study
14 de febrero de 2022 actualizado por: Eldad Arie Hod, Columbia University
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.
Descripción general del estudio
Estado
Activo, no reclutando
Condiciones
Descripción detallada
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.
Tipo de estudio
De observación
Inscripción (Actual)
75
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
New York
-
New York, New York, Estados Unidos, 10023
- Columbia University Medical Center
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 75 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
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.
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
|---|
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in mean iron content in specific brain nuclei
Periodo de tiempo: Up to 5 months
|
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
Periodo de tiempo: 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.
|
Up to 5 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Activity and connectivity in specific functional networks at resting state
Periodo de tiempo: 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.
|
Up to 5 months
|
|
Brain activity during tasks of processing speed and episodic memory
Periodo de tiempo: 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.
|
Up to 5 months
|
|
NIH Toolbox Auditory Verbal Learning Test (Rey) Score
Periodo de tiempo: 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.
|
Up to 5 months
|
|
NIH Toolbox Flanker Inhibitory Control and Attention Test Score
Periodo de tiempo: 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.
|
Up to 5 months
|
|
NIH Toolbox List Sorting Working Memory Test Score
Periodo de tiempo: 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.
|
Up to 5 months
|
|
NIH Toolbox Dimensional Change Card Sort Test
Periodo de tiempo: 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.
|
Up to 5 months
|
|
NIH Toolbox Pattern Comparison Processing Speed Test Score
Periodo de tiempo: 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.
|
Up to 5 months
|
|
NIH Toolbox Picture Sequence Memory Test
Periodo de tiempo: 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.
|
Up to 5 months
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Eldad Hod, MD, Associate Professor of Pathology and Cell Biology, Dept of Pathology&Cell Biology
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de enero de 2017
Finalización primaria (Anticipado)
1 de diciembre de 2022
Finalización del estudio (Anticipado)
1 de diciembre de 2022
Fechas de registro del estudio
Enviado por primera vez
9 de diciembre de 2016
Primero enviado que cumplió con los criterios de control de calidad
9 de diciembre de 2016
Publicado por primera vez (Estimar)
13 de diciembre de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
2 de marzo de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
14 de febrero de 2022
Última verificación
1 de febrero de 2022
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- AAAR0145
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .