Iron Deficiency Anemia and the Brain Study
This study is looking at how iron deficiency anemia (IDA) affects the brain and whether iron treatment can help. Researchers want to understand how IDA impacts thinking abilities, blood flow to the brain, and the brain's connections. They will also see if these effects can be reversed and how long any improvements last after iron treatment. The study involves women aged 16 to 60 with moderate to severe IDA, as well as women without anemia for comparison. Some participants will receive iron treatment with either Ferric derisomaltose or NovaFerrum, while others will be observed. The main goal is to measure how iron treatment affects oxygen delivery to the brain over 90 days and 365 days.
- Study design
- This study has two parts: an observational arm and an interventional arm, involving a total of 136 participants. In the interventional arm, 80 anemic subjects will be randomly assigned to receive either intravenous iron therapy or standard oral iron care.
- What's involved
- Participants will undergo comprehensive brain MRI scans, blood tests, complete questionnaires, and perform neurocognitive tests. These tests will be repeated at different times to track the effects of iron therapy.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 365 days after iron therapy to assess the long-term effects.
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Iron Deficiency Anemia (IDA) and the Brain
At a glance
Conditions
NCT05929729
Where you'd take part
This study runs at 4 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Cedar Sinai Blood Bank
Los Angeles, Californiastudy coordinator listed
Not yet recruiting
Children's Hospital Los Angeles
Los Angeles, Californiastudy coordinator listed
Recruiting
City of Hope Blood Donor Center
Duarte, Californiastudy coordinator listed
Not yet recruiting
University of California, Los Angeles Blood Donor Center
Los Angeles, Californiastudy coordinator listed
Not yet recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- John Wood, MD, PhD · PRINCIPAL_INVESTIGATOR · Children's Hospital Los Angeles
Who to contact
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What this trial measures
- Impact of iron deficiency anemia on regional cerebrovascular oxygen delivery (ml O2/100g/min).Day 0 (observation arm)
Baseline impact of iron deficiency anemia on cerebrovascular oxygen delivery will be assessed by measuring cerebral blood flow and oxygen content through MRI (time-encoded arterial spin labelling) and peripheral blood sample
- Impact of iron therapy on regional cerebrovascular oxygen delivery (ml O2/100g/min) in iron deficiency anemia at day 90 post therapyDay 90 post-iron-therapy
Impact of iron therapy on cerebrovascular oxygen delivery will be assessed at day 90 by measuring cerebral blood flow and oxygen content through MRI (time-encoded arterial spin labelling) and peripheral blood sample in people with iron deficiency anemia.
- Impact of iron therapy on regional cerebrovascular oxygen delivery (ml O2/100g/min) in iron deficiency anemia at day 365 post therapy.Day 365 post iron therapy
Impact of iron therapy on cerebrovascular oxygen delivery will be assessed at day 365 by measuring cerebral blood flow and oxygen content through MRI (time-encoded arterial spin labelling) and peripheral blood sample in people with iron deficiency anemia
- Impact of iron deficiency anemia on cerebrovascular flow reactivity (%SI change/%ETCO2)Day 0 (observation arm)
baseline MRI with blood oxygenation level dependent (BOLD) acquisition will be assessed in response to carbon dioxide exposure to determine whether iron deficiency anemia affects cerebrovascular reserve
- Impact of iron therapy on cerebrovascular flow reactivity (%SI change/%ETCO2) in people with iron deficiency anemia at 90 days post iron therapy.Day 90 post iron therapy
Impact of iron therapy on cardiovascular reserve in iron deficiency anemia will be assessed using MRI with blood oxygenation level dependent (BOLD) acquisition at 90 days post iron therapy.
- Impact of iron therapy on cerebrovascular flow reactivity (%SI change/%ETCO2) in people with iron deficiency anemia at day 365.Day 365 post iron therapy
Impact of iron therapy on cardiovascular reserve in iron deficiency anemia will be assessed using MRI with blood oxygenation level dependent (BOLD) acquisition at day 365 post iron therapy.
- Impact of iron deficiency anemia on blood brain barrier permeability surface area product (ml H20/100g/min)Day 0 (observation arm)
baseline PSA product using water-extraction-with phase- contrast-arterial-spin-tagging (WEPCAST) MRI will be assessed to determine whether iron deficiency anemia affects blood brain barrier permeability to water
- Impact of iron therapy on blood brain barrier permeability surface area product (ml H20/100g/min) in iron deficiency anemia will be assessed at 90 days.Day 90 post iron therapy
PSA product using water-extraction-with phase- contrast-arterial-spin-tagging (WEPCAST) MRI will be assessed at 90 days post iron therapy to determine the impact of iron therapy on blood brain barrier permeability to water in patients with iron deficiency anemia.
- Impact of iron therapy on blood brain barrier permeability surface area product (ml H20/100g/min) in iron deficiency anemia will be assessed again at day 365.Day 365 post iron therapy
PSA product using water-extraction-with phase- contrast-arterial-spin-tagging (WEPCAST) MRI will be assessed at 365 days post iron therapy to determine the impact of iron therapy on blood brain barrier permeability to water in patients with iron deficiency anemia.
- Impact of iron deficiency anemia on cerebral metabolic rate of oxygen (ml O2/100g/min).Day 0 (observation arm)
Baseline T2 relaxation under spin tagging (TRUST) acquisition via MRI will be used to assess any impact of iron deficiency anemia on cerebral metabolic rate of oxygen
- Impact of iron therapy on cerebral metabolic rate of oxygen (ml O2/100g/min) in people with iron deficiency anemia at day 90 post iron therapy.Day 90 post iron therapy
T2 relaxation under spin tagging (TRUST) acquisition via MRI will be used to assess any impact of iron therapy on cerebral metabolic rate of oxygen in anemic subjects at day 90.
- Impact of iron therapy on cerebral metabolic rate of oxygen (ml O2/100g/min) in people with iron deficiency anemia at day 365 post iron therapy.Day 365 post iron therapy
T2 relaxation under spin tagging (TRUST) acquisition via MRI will be used to assess any impact of iron therapy on cerebral metabolic rate of oxygen in anemic subjects at day 365.
- Impact of iron deficiency anemia on total brain blood flow (ml blood/100g/min).Day 0 (observation arm)
Phase contrast MRI will be assessed to determine whether iron deficiency anemia affects total brain blood flow at baseline
- Impact of iron therapy on total brain blood flow (ml blood/100g/min) in people with iron deficiency anemia at day 90Day 90 post iron therapy
Phase contrast MRI will be assessed at day 90 post iron therapy to determine whether iron therapy affects total brain blood flow in subjects with iron deficiency anemia
- Impact of iron therapy on total brain blood flow (ml blood/100g/min) in people with iron deficiency anemia at day 365Day 365 post iron therapy
Phase contrast MRI will be assessed at day 365 post iron therapy to determine whether iron therapy affects total brain blood flow in subjects with iron deficiency anemia
- Impact of iron deficiency anemia on visual-motor integration.Day 0 (observation arm)
Visual-motor integration at baseline (day 0) will be assessed using Beery Buktenica Developmental Test of Visual-Motor Integration (6th Edition). Standardized scores with a mean of 100 and a standard deviation of 15 are used. Higher scores mean better performance.
- Impact of iron therapy on visual-motor integration in people with iron deficiency anemia.Day 365 post iron therapy
Visual-motor integration will be assessed using Beery Buktenica Developmental Test of Visual-Motor Integration (6th Edition) at day 365 post iron-therapy. Standardized scores with a mean of 100 and a standard deviation of 15 are used. Higher scores mean better performance.
- Impact of iron deficiency anemia on sustained attention.Day 0 (observation arm)
Sustained attention at baseline (day 0) will be assessed using Conners' Continuous Performance Test (3rd Edition) at day 90 post iron-therapy. T-scores with a mean of 50 and a standard deviation of 10 are used. Higher scores mean worse performance.
- Impact of iron therapy on sustained attention in people with iron deficiency anemia.Day 365 post iron therapy
Sustained attention will be assessed using Conners' Continuous Performance Test (3rd Edition) at day 365 post iron-therapy. T-scores with a mean of 50 and a standard deviation of 10 are used. Higher scores mean worse performance.
- Impact of iron deficiency anemia on working memory function.Day 0 (observation arm)
Working memory function at baseline (day 0) will be assessed using Digit Span, Coding, and Symbol Search Subtests from Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV). Scaled scores with a mean of 10 and a standard deviation of 3 are used. Higher scores mean better performance.
- Impact of iron therapy on working memory function in people with iron deficiency anemia.Day 365 post iron therapy
Working memory function will be assessed at day 365 post iron therapy using Digit Span, Coding, and Symbol Search Subtests from Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV). Scaled scores with a mean of 10 and a standard deviation of 3 are used. Higher scores mean better performance.
- Impact of iron deficiency anemia on the ability to inhibit cognitive interferenceDay 0 (observation arm)
The ability to inhibit cognitive interference at baseline (day 0) will be assessed using Color-Word Interference Subtest from the Delis-Kaplan Executive Function System (D-KEFS). Scaled scores with a mean of 10 and a standard deviation of 3 are used. Higher scores mean better performance.
- Impact of iron therapy on the ability to inhibit cognitive interference in people with iron deficiency anemia.Day 365 post iron therapy
The ability to inhibit cognitive interference at day 365 post iron therapy will be assessed using Color-Word Interference Subtest from the Delis-Kaplan Executive Function System (D-KEFS). Scaled scores with a mean of 10 and a standard deviation of 3 are used. Higher scores mean better performance.
- Impact of iron deficiency anemia on fine motor control.Day 0 (observation arm)
Fine motor control will be assessed at baseline (day 0) using Reitan Finger Tapping. Z scores with a mean of zero and a standard deviation of one are used. Higher scores mean better performance.
- Impact of iron therapy on fine motor control in people with iron deficiency anemia.Day 365 post iron therapy
Fine motor control will be assessed at day 365 post iron therapy using Reitan Finger Tapping. Z scores with a mean of zero and a standard deviation of one are used. Higher scores mean better performance.
- Impact of iron therapy on list learning and recall task in people with iron deficiency anemia.Day 365 post iron therapy
List learning and recall task will be assessed at day 365 post iron therapy using California Verbal Learning Test-Third Edition (CVLT-3). Z scores with a mean of zero and a standard deviation of 1 are used. Higher scores mean better performance.
- Impact of iron deficiency anemia on visuospatial memoryDay 0 (observation arm)
Visuospatial memory will be assessed at baseline (day 0) using Brief Visuospatial Memory Test-Revised (BVMT-R). T-scores with a mean of 50 and a standard deviation of 10 are used. Higher scores mean better performance.
- Impact of iron therapy on visuospatial memory in people with iron deficiency anemia.Day 365 post iron therapy
Visuospatial memory will be assessed at day 365 post iron therapy using Brief Visuospatial Memory Test-Revised (BVMT-R). T-scores with a mean of 50 and a standard deviation of 10 are used. Higher scores mean better performance.
- Impact of iron deficiency anemia on general intellectual functioning, verbal and nonverbal abilities.Day 0 (observation arm)
General intellectual functioning, verbal and nonverbal abilities will be assessed at baseline (day 0) using Wechsler Abbreviated Scale of Intelligence-Second Edition (WASI-2). T scores with a mean of 50 and a standard deviation of 10 are used for the subtests, with standard scores (mean of 100 and standard deviation of 15) used for composite scores. Higher scores mean better performance.
- Impact of iron therapy on general intellectual functioning, verbal and nonverbal abilities in people with iron deficiency anemia.Day 365 post iron therapy
General intellectual functioning, verbal and nonverbal abilities will be assessed at day 365 post iron therapy using Wechsler Abbreviated Scale of Intelligence-Second Edition (WASI-2). T scores with a mean of 50 and a standard deviation of 10 are used for the subtests, with standard scores (mean of 100 and standard deviation of 15) used for composite scores. Higher scores mean better performance.
- Impact of iron deficiency anemia on cognitive flexibility and processing speed.Day 0 (observation arm)
Cognitive flexibility and processing speed will be assessed at baseline (day 0) using NIH Toolbox: Dimensional Change Card Sort and Pattern Comparison Processing Speed. Standard scores with a mean of 100 and a standard deviation of 15 are used. Higher scores mean better performance.
- Impact of iron therapy on cognitive flexibility and processing speed in people with iron deficiency anemia.Day 365 post iron therapy
Cognitive flexibility and processing speed will be assessed at day 365 post iron therapy using NIH Toolbox: Dimensional Change Card Sort and Pattern Comparison Processing Speed. Standard scores with a mean of 100 and a standard deviation of 15 are used. Higher scores mean better performance.
- Impact of iron deficiency anemia on list learning and recall taskDay 0 (observation arm)
List learning and recall task will be assessed at baseline (day 0) using California Verbal Learning Test-Third Edition (CVLT-3). Z scores with a mean of zero and a standard deviation of 1 are used. Higher scores mean better performance.
- Impact of iron deficiency anemia on emotional healthDay 0 (observation arm)
Emotional health will be assessed by using NIH toolbox emotion battery at baseline. T-scores with a mean of 50 and a standard deviation of 10 are used. Higher scores mean higher number/frequency of symptoms.
- Impact of iron therapy on emotional health in people with iron deficiency anemia.Day 365 post iron therapy
Emotional health will be assessed at day 365 post iron therapy by using NIH toolbox emotion battery. T-scores with a mean of 50 and a standard deviation of 10 are used. Higher scores mean higher number/frequency of symptoms.
- Impact of iron deficiency anemia on executive functions in day-to-day life.Day 0 (observation arm)
Executive functions in day-to-day life will be assessed at baseline using the Behavior Rating Inventory of Executive Function 2 (BRIEF-2). T-scores with a mean of 50 and a standard deviation of 10 are used. Scores above T=65 may indicated problems.
- Impact of iron therapy on executive functions in day-to-day life in people with iron deficiency anemia.Day 365 post iron therapy
Executive functions in day-to-day life will be assessed at day 365 using the Behavior Rating Inventory of Executive Function 2 (BRIEF-2). T-scores with a mean of 50 and a standard deviation of 10 are used. Scores above T=65 may indicated problems.