Iron Deficiency Anemia (IDA)

• Status: Not yet recruiting
• Trial end date: 2028-09-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Children's Hospital Los Angeles

Criteria

Inclusion Criteria:

• Observational arm:

1. Age between 18 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.