Neurovascular and Neurocognitive Consequences of Iron Deficiency Anemia

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 16
Maximum Age: 60
Healthy Volunteers: t
View:

• 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

Locations
United States
California
City of Hope Blood Donor Center
NOT_YET_RECRUITING
Duarte
Cedar Sinai Blood Bank
NOT_YET_RECRUITING
Los Angeles
Children's Hospital Los Angeles
RECRUITING
Los Angeles
University of California, Los Angeles Blood Donor Center
NOT_YET_RECRUITING
Los Angeles
Contact Information
Primary
Silvie Suriany, MSc
anemia@chla.usc.edu
323-361-4783
Time Frame
Start Date: 2023-12-07
Estimated Completion Date: 2028-09-01
Participants
Target number of participants: 120
Treatments
Experimental: Intravenous (IV) iron
This group will receive intravenous iron (Ferric Derisomaltose) in a single dose of 20 mg/kg (max individual dose of 1000 mg). The drug is administered as an infusion over 30 minutes. 3 months after the infusion, they will receive a 9-month supply of Novaferrum pill to be taken once a day.
No_intervention: Standard of care iron
This group will be referred to their primary care provider for oral iron therapy. If a participant cannot obtain care from a physician
No_intervention: Healthy Controls
This group will only be participating in the observational part of the study and serve as our controls.
Related Therapeutic Areas
Sponsors
Leads: Children's Hospital Los Angeles
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)

This content was sourced from clinicaltrials.gov

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