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Iron Deficiency Anemia (IDA) and the Brain

Children's Hospital Los Angeles · with National Institute of Neurological Disorders and Stroke (NINDS) · NCT05929729

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 16–60 · Women only
Healthy volunteers
Accepted
Study type
Interventional · Phase 4
Target enrollment
120
US sites recruiting
1
Study start
December 7, 2023
Record last updated
October 30, 2024

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Ferric derisomaltose; NovaFerrum

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

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • Observational arm:
  • Age between 16 and 60 years of age.
  • Any ethnicity.
  • Female
  • Anemic group: hemoglobin ≤10.5 g/dl or hematocrit \<32% from finger prick or plethysmography test, or \<11 g/dl from venipuncture blood draw
  • Control group: hemoglobin >13.2 g/dl or hematocrit >39.6%
  • Interventional arm:
  • Criteria for observational component, plus
  • 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:
  • Diabetes requiring medication.
  • Hypertension requiring medication.
  • Sleep disordered breathing requiring intervention.
  • Body mass index >40 (morbid obesity)
  • Contraindications to MRI, including pacemaker, severe claustrophobia, pregnancy.
  • Known systemic inflammatory disease such as inflammatory bowel disease, systemic lupus erythematosus, or scleroderma.
  • Known HIV.
  • Interventional arm:
  • Criteria for observational component, plus
  • Prior reaction to intravenous iron.
  • History of multiple drug allergies.
  • History of severe asthma, eczema, or atopy.
  • Systemic mastocytosis.
  • Severe respiratory or cardiac disease.
  • Having no access to a physician who can manage the iron deficiency anemia.

Recruiting US locations

  • Children's Hospital Los Angeles

    Los Angeles, CA 90027

    Site contact: Silvie Suriany, MSc · 323-361-4783 · anemia@chla.usc.edu

Study contacts (from the official record)

  • Silvie Suriany, MSc · 323-361-4783 · anemia@chla.usc.edu
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Iron Deficiency Anemia (IDA) and the Brain (NCT05929729) | Bored Studies