Iron Deficiency Anemia (IDA) and the Brain

DRUG

Ferric derisomaltose

Refer to arm/group descriptions

DRUG

NovaFerrum

Refer to arm/group descriptions

Impact of iron deficiency anemia on regional cerebrovascular oxygen delivery (ml O2/100g/min).

Time frame: 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 therapy

Time frame: Day 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.

Time frame: 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)

Time frame: 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.

Time frame: 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.

Time frame: 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)

Time frame: 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.

Time frame: 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.

Time frame: 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).

Time frame: 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.

Time frame: 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.

Time frame: 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).

Time frame: 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 90

Time frame: Day 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 365

Time frame: Day 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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 interference

Time frame: Day 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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 memory

Time frame: Day 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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 task

Time frame: Day 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 health

Time frame: Day 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

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