Home › Iron-Deficiency Anemia › NCT05929729
Iron Deficiency Anemia (IDA) and the Brain
Neurovascular and Neurocognitive Consequences of Iron Deficiency Anemia
Who can join
Ages 16 to 60 · Women · Healthy volunteers welcome
Full eligibility criteria
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.
About the study
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.
What is being tested
- Ferric derisomaltose (drug)
- NovaFerrum (drug)
Sponsor: Children's Hospital Los Angeles · Participants: 120 · Started: Dec 7, 2023
Contact the study team
- Silvie Suriany, MSc · Phone: 323-361-4783
Official record on ClinicalTrials.gov — NCT05929729
Locations in the U.S.
| California | City of Hope Blood Donor Center, Duarte (Not yet recruiting) Cedar Sinai Blood Bank, Los Angeles (Not yet recruiting) Children's Hospital Los Angeles, Los Angeles University of California, Los Angeles Blood Donor Center, Los Angeles (Not yet recruiting) |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.