Iron Deficiency Anemia (IDA) and the Brain

Launched by CHILDREN'S HOSPITAL LOS ANGELES · Jun 16, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how iron deficiency anemia (IDA) affects brain function in adult women. Researchers want to understand the impact of IDA on thinking and memory, and how well blood flows to the brain in these patients. They will also investigate if replacing iron can help improve both brain function and blood flow, and how long these improvements last. The study includes two groups: one group will be observed without treatment, and the other will receive iron replacement therapy.

To be eligible for the trial, participants should be women aged 16 to 60 who have moderate to severe anemia, indicated by low hemoglobin levels. There is also a control group for women with normal hemoglobin levels. Participants will need to provide informed consent before joining the study. Those with certain health conditions, like diabetes or severe obesity, or who are pregnant, may not qualify. If you decide to participate, you can expect to undergo tests that will help researchers learn more about the effects of IDA on your brain and overall health.

Gender

FEMALE

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.