Iron Deficiency Anemia (IDA) and the Brain

Part of paid clinical trials in Duarte, California.

Sponsor
Children's Hospital Los Angeles
Study ID
NCT05929729
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
16 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • Ferric derisomaltose — DRUG
    Refer to arm/group descriptions
  • NovaFerrum — DRUG
    Refer to arm/group descriptions

Study 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.

Key Dates

Start date
Dec 7, 2023
Status verified
Jul 2024
Primary completion
Sep 1, 2028
Completion
Sep 1, 2028

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • 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.

Primary Outcome Measure

Impact of iron deficiency anemia on regional cerebrovascular oxygen delivery (ml O2/100g/min). [ Time Frame: Day 0 (observation arm) ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
City of Hope Blood Donor CenterDuarteCalifornia91010
Silvie Suriany, MSc
[email protected]
323-361-4783
Lefan Zhuang, MD
[email protected]
Cedar Sinai Blood BankLos AngelesCalifornia90027-6062
Silvie Suriany, MSc
[email protected]
323-361-4783
Ellen Klapper, MD
[email protected]
Children's Hospital Los AngelesLos AngelesCalifornia90027
Silvie Suriany, MSc
[email protected]
323-361-4783
John Wood, MD,PhD
University of California, Los Angeles Blood Donor CenterLos AngelesCalifornia90095
Silvie Suriany, MSc
[email protected]
323-361-4783
Dawn Ward, MD
[email protected]

Find similar trials in Duarte, CA

By research site
City of Hope Blood Donor Center· Duarte, CACedar Sinai Blood Bank· Los Angeles, CAChildren's Hospital Los Angeles· Los Angeles, CAUniversity of California, Los Angeles Blood Donor Center· Los Angeles, CA

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