Clinical trial
Neurovascular and Neurocognitive Consequences of Iron Deficiency Anemia
Name
CHLA-23-00173
Description
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.
Trial arms
Trial start
2023-12-01
Estimated PCD
2028-09-01
Trial end
2028-09-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
Ferric derisomaltose
Refer to arm/group descriptions
Arms:
Intravenous (IV) iron
NovaFerrum
Refer to arm/group descriptions
Arms:
Intravenous (IV) iron
Size
136
Primary endpoint
Impact of iron deficiency anemia on regional cerebrovascular oxygen delivery (ml O2/100g/min).
Day 0 (observation arm)
Impact of iron therapy on regional cerebrovascular oxygen delivery (ml O2/100g/min) in iron deficiency anemia at day 90 post therapy
Day 90 post-iron-therapy
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 deficiency anemia on cerebrovascular flow reactivity (%SI change/%ETCO2)
Day 0 (observation arm)
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 cerebrovascular flow reactivity (%SI change/%ETCO2) in people with iron deficiency anemia at day 365.
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)
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
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
Impact of iron deficiency anemia on cerebral metabolic rate of oxygen (ml O2/100g/min).
Day 0 (observation arm)
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
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
Impact of iron deficiency anemia on total brain blood flow (ml blood/100g/min).
Day 0 (observation arm)
Impact of iron therapy on total brain blood flow (ml blood/100g/min) in people with iron deficiency anemia at day 90
Day 90 post iron therapy
Impact of iron therapy on total brain blood flow (ml blood/100g/min) in people with iron deficiency anemia at day 365
Day 365 post iron therapy
Impact of iron deficiency anemia on visual-motor integration.
Day 0 (observation arm)
Impact of iron therapy on visual-motor integration in people with iron deficiency anemia.
Day 365 post iron therapy
Impact of iron deficiency anemia on sustained attention.
Day 0 (observation arm)
Impact of iron therapy on sustained attention in people with iron deficiency anemia.
Day 365 post iron therapy
Impact of iron deficiency anemia on working memory function.
Day 0 (observation arm)
Impact of iron therapy on working memory function in people with iron deficiency anemia.
Day 365 post iron therapy
Impact of iron deficiency anemia on the ability to inhibit cognitive interference
Day 0 (observation arm)
Impact of iron therapy on the ability to inhibit cognitive interference in people with iron deficiency anemia.
Day 365 post iron therapy
Impact of iron deficiency anemia on fine motor control.
Day 0 (observation arm)
Impact of iron therapy on fine motor control in people with iron deficiency anemia.
Day 365 post iron therapy
Impact of iron therapy on list learning and recall task in people with iron deficiency anemia.
Day 365 post iron therapy
Impact of iron deficiency anemia on visuospatial memory
Day 0 (observation arm)
Impact of iron therapy on visuospatial memory in people with iron deficiency anemia.
Day 365 post iron therapy
Impact of iron deficiency anemia on general intellectual functioning, verbal and nonverbal abilities.
Day 0 (observation arm)
Impact of iron therapy on general intellectual functioning, verbal and nonverbal abilities in people with iron deficiency anemia.
Day 365 post iron therapy
Impact of iron deficiency anemia on cognitive flexibility and processing speed.
Day 0 (observation arm)
Impact of iron therapy on cognitive flexibility and processing speed in people with iron deficiency anemia.
Day 365 post iron therapy
Impact of iron deficiency anemia on list learning and recall task
Day 0 (observation arm)
Impact of iron deficiency anemia on emotional health
Day 0 (observation arm)
Impact of iron therapy on emotional health in people with iron deficiency anemia.
Day 365 post iron therapy
Impact of iron deficiency anemia on executive functions in day-to-day life.
Day 0 (observation arm)
Impact of iron therapy on executive functions in day-to-day life in people with iron deficiency anemia.
Day 365 post iron therapy
Eligibility criteria
Inclusion Criteria:
* Observational arm:
1. Age between 18 and 60 years of age.
2. Any ethnicity.
3. Female
4. Anemic group: hemoglobin ≤10.5 g/dl or hematocrit \<32% from finger prick or plethysmography test, or \<11 g/dl from venipuncture blood draw
5. Control group: hemoglobin \>13.2 g/dl or hematocrit \>39.6%
* Interventional arm:
1. Criteria for observational component, plus
2. Iron deficiency anemia based upon attending hematologist interpretation of transferrin saturation, ferritin, and other ancillary labs including hs-CRP, MMA, hemoglobin electrophoresis
Exclusion Criteria:
* Observational arm:
1. Diabetes requiring medication.
2. Hypertension requiring medication.
3. Sleep disordered breathing requiring intervention.
4. Body mass index \>40 (morbid obesity)
5. Contraindications to MRI, including pacemaker, severe claustrophobia, pregnancy.
6. Known systemic inflammatory disease such as inflammatory bowel disease, systemic lupus erythematosus, or scleroderma.
7. Known HIV.
* Interventional arm:
1. Criteria for observational component, plus
2. Prior reaction to intravenous iron.
3. History of multiple drug allergies.
4. History of severe asthma, eczema, or atopy.
5. Systemic mastocytosis.
6. Severe respiratory or cardiac disease.
7. Having no access to a physician who can manage the iron deficiency anemia.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 136, 'type': 'ESTIMATED'}}
Updated at
2023-11-18
1 organization
2 products
3 indications
Organization
Children's Hospital Los AngelesProduct
Ferric derisomaltoseIndication
Iron Deficiency AnemiaIndication
AnaemiaIndication
Iron DeficiencyProduct
NovaFerrum