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Iron Deficiency Anemia (IDA) and the Brain

Study acronym: IDA
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Enrollment target: 108 to 120
    • Eligibility criteria revised
    • Site contacts updated at 4 of 4 sites
    v6
  2. Trial status: Not Yet Recruiting to Recruitingv5 Show 5 more changesShow less
    • Enrollment target: 136 to 108
    • Start date changed from estimate of Dec 1, 2023 to Dec 7, 2023
    • Site details revised at 4 of 4 sites
    • Collaborators expanded, about 8 words
    • Study title expanded, about 3 words
  3. Interventions: Ferric carboxymaltose (Drug), ferrous sulfate (Drug) to Ferric derisomaltose (Drug), NovaFerrum (Drug)
    • Eligibility criteria expanded, about 13 words
    v4
  4. Start date: Aug 1, 2023 to Dec 1, 2023
    • Study title expanded, about 1 word
    v3
  5. Start date: Jul 1, 2023 to Aug 1, 2023v2 Show 4 more changesShow less
    • Enrollment target: 96 to 136
    • Primary and study completion dates: Aug 1, 2028 to Sep 1, 2028
    • Study description expanded, about 36 words
    • Study arms: 2 to 3
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05929729
Lead Sponsor Children's Hospital Los Angeles
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)
Conditions
(from sponsor)		 IDA - Iron Deficiency Anemia, Anemia, Iron Deficiency Anemia, Anemia, Iron Deficiency
Related terms Anemia, Anemia, Iron-Deficiency
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov