Iron Deficiency Anemia (IDA) and the Brain
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age16-60
SponsorChildren's Hospital Los Angeles
About this trial
This is a trial with an observational and an interventional arm, in patients with moderate to severe anemia and control subjects. The main purposes of this study is to phenotype the scope of neurocognitive deficits from iron deficiency anemia (IDA) in adult women, determine derangements in cerebral perfusion, vascular reactivity, functional connectivity, and blood brain barrier permeability in adult-onset IDA and relate them to neurocognitive deficits, as well as determine the reversibility and durability of both the physiologic and neurocognitive derangements by iron replacement therapy. All eligible subjects will be asked to provide informed consent before participating in the study.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age between 16 and 60 years of age.
Any ethnicity.
Female
Anemic group: hemoglobin ≤10.5 g/dl or hematocrit <32% from finger prick or plethysmography test, or <11 g/dl from venipuncture blood draw
Disqualifiers
Diabetes requiring medication.
Hypertension requiring medication.
Sleep disordered breathing requiring intervention.
Body mass index >40 (morbid obesity)
Trial design
Design model
Parallel
Treatments tested in this trial
Ferric derisomaltose
DrugRefer to arm/group descriptions
NovaFerrum
DrugRefer to arm/group descriptions
Treatment groups
120 Participants
are divided into 3 treatment groupsGroup A: Intravenous (IV) ironExperimental treatment 2 interventions
Group B: Standard of care ironNo intervention 0 interventions
Group C: Healthy ControlsNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Impact of iron deficiency anemia on regional cerebrovascular oxygen delivery (ml O2/100g/min).
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
Time frame
Day 0 (observation arm)2
Impact of iron therapy on regional cerebrovascular oxygen delivery (ml O2/100g/min) in iron deficiency anemia at day 90 post 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.
Time frame
Day 90 post-iron-therapy3
Impact of iron therapy on regional cerebrovascular oxygen delivery (ml O2/100g/min) in iron deficiency anemia at day 365 post 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
Time frame
Day 365 post iron therapy4
Impact of iron deficiency anemia on cerebrovascular flow reactivity (%SI change/%ETCO2)
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
Time frame
Day 0 (observation arm)Secondary outcomes
1
Patient reported outcomes of health and quality of life will be assessed at baseline.
Rand Short Form Health Survey will be obtained at baseline. Score range is 0-100. Higher score means better quality of life.
Time frame
Day 0 (observation arm)2
Changes in patient reported outcomes of health and quality of life will be assessed over a period of 1 year post iron therapy.
Any effects and the changes in the effects of iron therapy will be assessed by obtaining the Rand Short Form Health Survey again post therapy at day 14 (for intravenous (IV) iron group only), day 90, day 180 and day 365 post iron therapy. Score range is 0-100. Higher score means better quality of life.
Time frame
Day 14 (for IV iron group only), Day 90, Day 180, Day 3653
Patient reported outcomes of fatigue will be assessed at baseline.
Functional Assessment of Chronic Illness Therapy will be obtained at baseline. Score range is 0-52. Higher score means less fatigue.
Time frame
Day 0 (observation arm)4
Changes in patient reported outcomes of fatigue will be assessed over a period of 1 year post iron therapy.
Any effects and the changes in the effects of iron therapy will be assessed by obtaining the Functional Assessment of Chronic Illness Therapy again post therapy at day 14 (for intravenous (IV) iron group only), day 90, day 180 and day 365 post iron therapy. Score range is 0-52. Higher score means less fatigue.
Time frame
Day 14 (for IV iron group only), Day 90, Day 180, Day 365Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Children's Hospital Los Angeles
Lead sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Source ClinicalTrials.gov