NCT05929729

Iron Deficiency Anemia (IDA) and the Brain

Neurovascular and Neurocognitive Consequences of Iron Deficiency Anemia

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Children's Hospital Los Angeles · Academic / Other
• Sex: Female
• Age: 16 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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. Comprehensive cerebrovascular magnetic resonance imaging (MRI), bloodwork, patient reported outcomes, and neurocognitive testing will be collected from all subjects in the observational arm. 136 subjects total will be enrolled, 40 controls and 96 anemic subjects. The 96 eligible anemic subjects will then be invited to enroll in the interventional arm of the study. Anticipating a drop-out rate of 20%, 40 will be randomized into intravenous iron therapy, and 40 will be randomized into standard of care (oral iron via primary care). Repeated tests will be done at different timepoints to assess the effects and durability of iron therapy.

Conditions

• IDA - Iron Deficiency Anemia
• Anemia
• Iron Deficiency Anemia
• Anemia, Iron Deficiency

Interventions

Type	Name	Description
DRUG	Ferric derisomaltose	Refer to arm/group descriptions
DRUG	NovaFerrum	Refer to arm/group descriptions

Timeline

• Start date: 2023-12-07
• Primary completion: 2028-09-01
• Completion: 2028-09-01
• First posted: 2023-07-03
• Last updated: 2024-10-30

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study