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

Qualifiers

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

Treatments tested in this trial

  • Ferric derisomaltose
  • NovaFerrum

Treatment groups

120 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Children's Hospital Los Angeles

Lead sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator