Back to Trials
NCT05929729PHASE4RecruitingAccepts Healthy Volunteers

Iron Deficiency Anemia (IDA) and the Brain

Children's Hospital Los Angeles

Start Date

12/7/2023

Completion Date

9/1/2028

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.

Eligibility Criteria

Age Range: 16 years to 60 years

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.

Interventions

DRUG

Ferric derisomaltose

DRUG

NovaFerrum

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

IDA - Iron Deficiency AnemiaAnemiaIron Deficiency AnemiaAnemia, Iron Deficiency

Locations

City of Hope Blood Donor Center

Duarte, California 91010

United States

Cedar Sinai Blood Bank

Los Angeles, California 90027-6062

United States

Children's Hospital Los Angeles

Los Angeles, California 90027

United States

University of California, Los Angeles Blood Donor Center

Los Angeles, California 90095

United States