drugset / Trial / NCT05929729
Iron Deficiency Anemia (IDA) and the Brain
Phase 4
Recruiting
120 enrolled
Children's Hospital Los Angeles
National Institute of Neurological Disorders and Stroke (NINDS) · collab
RandomizedParallel-groupOpen-labelBasic science
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.
Timeline
- Start
- 2023-12-07
- Primary completion
- 2028-09-01
- Completion
- 2028-09-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ferric Derisomaltose | Unknown | 20 mg/kg | Intravenous |
| Background | NovaFerrum | Unknown | — | Oral |