Iron Deficiency Anemia (IDA) and the Brain

Last updated: October 28, 2024
Sponsor: Children's Hospital Los Angeles
Overall Status: Active - Recruiting

Phase

4

Condition

Anemia

Treatment

Ferric derisomaltose

NovaFerrum

Ferric carboxymaltose

Clinical Study ID

NCT05929729
CHLA-23-00173
1R01NS117430-01
  • Ages 16-60
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 orplethysmography 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 oftransferrin saturation, ferritin, and other ancillary labs including hs-CRP,MMA, hemoglobin electrophoresis

Exclusion

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.

Study Design

Total Participants: 120
Treatment Group(s): 4
Primary Treatment: Ferric derisomaltose
Phase: 4
Study Start date:
December 07, 2023
Estimated Completion Date:
September 01, 2028

Study 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.

Connect with a study center

  • City of Hope Blood Donor Center

    Duarte, California 91010
    United States

    Site Not Available

  • Cedar Sinai Blood Bank

    Los Angeles, California 90027-6062
    United States

    Site Not Available

  • Children's Hospital Los Angeles

    Los Angeles, California 90027
    United States

    Active - Recruiting

  • University of California, Los Angeles Blood Donor Center

    Los Angeles, California 90095
    United States

    Site Not Available

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