Actively Recruiting
Iron Deficiency Anemia (IDA) and the Brain
Led by Children's Hospital Los Angeles · Updated on 2024-10-30
120
Participants Needed
4
Research Sites
247 weeks
Total Duration
On this page
Sponsors
C
Children's Hospital Los Angeles
Lead Sponsor
N
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborating Sponsor
AI-Summary
What this Trial 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.
CONDITIONS
Official Title
Iron Deficiency Anemia (IDA) and the Brain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 16 and 60 years
- Female gender
- Any ethnicity
- For anemic group: hemoglobin 6410.5 g/dl or hematocrit <32% from finger prick or plethysmography test, or <11 g/dl from venipuncture blood draw
- For control group: hemoglobin >13.2 g/dl or hematocrit >39.6%
- For interventional arm: diagnosis of iron deficiency anemia confirmed by hematologist based on transferrin saturation, ferritin, and other lab tests including hs-CRP, MMA, and hemoglobin electrophoresis
You will not qualify if you...
- 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 diseases such as inflammatory bowel disease, systemic lupus erythematosus, or scleroderma
- Known HIV infection
- For interventional arm: prior reaction to intravenous iron
- History of multiple drug allergies
- History of severe asthma, eczema, or atopy
- Systemic mastocytosis
- Severe respiratory or cardiac disease
- No access to a physician who can manage iron deficiency anemia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
City of Hope Blood Donor Center
Duarte, California, United States, 91010
Not Yet Recruiting
2
Cedar Sinai Blood Bank
Los Angeles, California, United States, 90027-6062
Not Yet Recruiting
3
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
Actively Recruiting
4
University of California, Los Angeles Blood Donor Center
Los Angeles, California, United States, 90095
Not Yet Recruiting
Research Team
S
Silvie Suriany, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
3
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