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Iron Deficiency Anemia (IDA) and the Brain

RecruitingPhase 4Ages 16 Years - 60 YearsFemaleChildren's Hospital Los Angeles
NCT05929729 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Observational arm: 1. Age between 16 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.
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What it tests

  • Ferric derisomaltose
  • NovaFerrum
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Where

4 sites
City of Hope Blood Donor Center
Duarte, United States
Cedar Sinai Blood Bank
Los Angeles, United States
Children's Hospital Los Angeles
Los Angeles, United States
University of California, Los Angeles Blood Donor Center
Los Angeles, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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