Not currently recruiting at University of California Health

Iron Deficiency Anemia (IDA) and the Brain

a study on Anemia

Summary

Eligibility
for females ages 16-60 (full criteria)
Healthy Volunteers
healthy people welcome
Location
at UCLA
Dates
study started
completion around

Description

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.

Official Title

Neurovascular and Neurocognitive Consequences of Iron Deficiency Anemia

Details

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.

Comprehensive cerebrovascular magnetic resonance imaging (MRI), bloodwork, patient reported outcomes, and neurocognitive testing will be collected from all subjects in the observational arm. 136 subjects total will be enrolled, 40 controls and 96 anemic subjects. The 96 eligible anemic subjects will then be invited to enroll in the interventional arm of the study. Anticipating a drop-out rate of 20%, 40 will be randomized into intravenous iron therapy, and 40 will be randomized into standard of care (oral iron via primary care). Repeated tests will be done at different timepoints to assess the effects and durability of iron therapy.

Keywords

IDA - Iron Deficiency Anemia, Anemia, Iron Deficiency Anemia, Anemia, Iron Deficiency, Iron-Deficiency Anemia, Iron Deficiencies, Deficiency Diseases, Ferric derisomaltose, NovaFerrum, Intravenous (IV) iron

Eligibility

You can join if…

Open to females ages 16-60

  • 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

You CAN'T join if...

  • 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.

Locations

  • University of California, Los Angeles Blood Donor Center not yet accepting patients
    Los Angeles California 90095 United States
  • Cedar Sinai Blood Bank not yet accepting patients
    Los Angeles California 90027-6062 United States
  • Children's Hospital Los Angeles accepting new patients
    Los Angeles California 90027 United States
  • City of Hope Blood Donor Center not yet accepting patients
    Duarte California 91010 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Children's Hospital Los Angeles
ID
NCT05929729
Phase
Phase 4 Anemia Research Study
Study Type
Interventional
Participants
Expecting 120 study participants
Last Updated