Investigating the effects of iron deficiency anemia on brain function

Neurovascular and Neurocognitive Consequences of Iron Deficiency Anemia

This study is testing how iron deficiency anemia affects brain function in adult women and whether treating it with iron can improve their cognitive abilities.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 16 Years to 60 Years
• Sex: Female
• Sponsor: Children's Hospital Los Angeles (Academic / other)
• Locations: 4 sites (Duarte, California and 3 other locations)
• Trial ID: NCT05929729 on ClinicalTrials.gov

What this trial studies

This trial includes both observational and interventional components aimed at understanding the neurocognitive deficits associated with iron deficiency anemia (IDA) in adult women. It will assess cerebral perfusion, vascular reactivity, functional connectivity, and blood-brain barrier permeability in patients with moderate to severe anemia compared to control subjects. Participants will undergo comprehensive cerebrovascular MRI, bloodwork, and neurocognitive testing, with an interventional arm involving randomized treatment with intravenous iron therapy or standard oral iron therapy. The study aims to evaluate the reversibility of physiological and cognitive impairments through iron replacement therapy.

Who should consider this trial

Good fit: Ideal candidates are adult women aged 16 to 60 with moderate to severe iron deficiency anemia.

Not a fit: Patients with conditions such as diabetes, hypertension requiring medication, or morbid obesity may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment strategies for cognitive deficits associated with iron deficiency anemia.

How similar studies have performed: Other studies have shown promising results in understanding the cognitive impacts of anemia, but this specific approach is novel.

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.

Where this trial is running

Duarte, California and 3 other locations

• City of Hope Blood Donor Center — Duarte, California, United States (Not_yet_recruiting)
• Cedar Sinai Blood Bank — Los Angeles, California, United States (Not_yet_recruiting)
• Children's Hospital Los Angeles — Los Angeles, California, United States (Recruiting)
• University of California, Los Angeles Blood Donor Center — Los Angeles, California, United States (Not_yet_recruiting)

Study contacts

• Principal investigator: John Wood, MD, PhD — Children's Hospital Los Angeles
• Study coordinator: Silvie Suriany, MSc

Conditions IDA - Iron Deficiency Anemia; Anemia; Iron Deficiency Anemia; Anemia, Iron Deficiency