Iron Deficiency Anemia (IDA) and the Brain
Key facts
- Who runs it
- Children's Hospital Los Angeles
- Where
- Duarte and Los Angeles, United StatesSee the 4 sites
- Trial code
- Status
- Recruiting
- Phase
- Phase 4
- People taking part
- 120 people, planned
- Started
- 7 Dec 2023
- Expected to end
- 1 Sept 2028
- Type of study
- Interventional, 3 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- Ferric derisomaltose
- NovaFerrum
- Record updated
- 30 October 2024
Who can take part
- Age
- 16 years to 60 years
- Sex
- Women only
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 4 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 16 and 60 years old?
Where in United States
- City of Hope Blood Donor CenterDuarte, United StatesContact: Silvie Suriany, MScNot yet recruiting
- Cedar Sinai Blood BankLos Angeles, United StatesContact: Silvie Suriany, MScNot yet recruiting
- Children's Hospital Los AngelesLos Angeles, United StatesContact: Silvie Suriany, MScTaking people
- University of California, Los Angeles Blood Donor CenterLos Angeles, United StatesContact: Silvie Suriany, MScNot yet recruiting
About the trial
What the trial wants to find out
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.
The 3 groups in the trial
- Intravenous (IV) ironTreatment being tested
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.
Treatment: Ferric derisomaltose and NovaFerrum
- Standard of care ironNo study treatment, for comparison
This group will be referred to their primary care provider for oral iron therapy. If a participant cannot obtain care from a physician
- Healthy ControlsNo study treatment, for comparison
This group will only be participating in the observational part of the study and serve as our controls.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Neurovascular and Neurocognitive Consequences of Iron Deficiency Anemia
- Fit questions
- Built from NCT05929729, who can take part
- Record updated
- 30 October 2024