Investigating the effects of iron deficiency anemia on brain function

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Children's Hospital Los Angeles
  Los Angeles, California, United States Recruiting
• 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
• 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
• Email: anemia@chla.usc.edu
• Phone: 323-361-4783

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.