Iron Deficiency Anemia (IDA) and the Brain

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.

Conditions

IDA - Iron Deficiency Anemia, Anemia, Iron Deficiency Anemia, Anemia, Iron Deficiency

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Study Overview

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Study Details

Study overview

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.

Neurovascular and Neurocognitive Consequences of Iron Deficiency Anemia

Iron Deficiency Anemia (IDA) and the Brain

Condition
IDA - Iron Deficiency Anemia
Intervention / Treatment

-

Contacts and Locations

Duarte

City of Hope Blood Donor Center, Duarte, California, United States, 91010

Los Angeles

Cedar Sinai Blood Bank, Los Angeles, California, United States, 90027-6062

Los Angeles

Children's Hospital Los Angeles, Los Angeles, California, United States, 90027

Los Angeles

University of California, Los Angeles Blood Donor Center, Los Angeles, California, United States, 90095

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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.

Ages Eligible for Study

16 Years to 60 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Children's Hospital Los Angeles,

John Wood, MD, PhD, PRINCIPAL_INVESTIGATOR, Children's Hospital Los Angeles

Study Record Dates

2028-09-01