Actively Recruiting
Neurovascular and Neurocognitive Consequences of Iron Deficiency Anemia in Adult Women
Led by Children's Hospital Los Angeles · Updated on 2024-10-30
120
Participants Needed
4
Research Sites
N/A
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
Researchers are studying adult women with moderate to severe iron deficiency anemia (IDA) and healthy controls to understand how IDA affects brain function and blood flow. The study aims to identify neurocognitive problems linked to IDA and examine changes in brain blood flow, vascular health, and blood-brain barrier function. It also investigates whether iron replacement therapy can reverse these brain and cognitive changes and how long these effects last. The study includes both observational and interventional parts. All participants undergo brain MRI scans, blood tests, patient surveys, and cognitive testing. In the interventional part, women with IDA are randomly assigned to receive either intravenous iron therapy (Ferric Derisomaltose) followed by daily oral iron (Novaferrum) or standard oral iron treatment through their primary care provider. A control group of healthy women participates only in the observational assessments. Tests are repeated over one year to monitor treatment effects and durability. Participants will attend multiple visits for MRI scans, blood work, symptom questionnaires, and neurocognitive tests. These assessments occur at baseline, 14 days, 90 days, 180 days, and one year after treatment starts. Researchers will measure brain oxygen delivery, blood flow, cognitive abilities, and quality of life, as well as iron levels and symptoms like restless legs syndrome. Safety is monitored throughout, and informed consent is required before joining. Total participation can last up to one year.
CONDITIONS
Brief Title
Iron Deficiency Anemia (IDA) and the Brain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Females aged between 16 and 60 years
- Any ethnicity
- For anemic group: hemoglobin ≤10.5 g/dl or hematocrit <32% by finger prick or plethysmography, or <11 g/dl by 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 using lab tests including transferrin saturation, ferritin, hs-CRP, MMA, and hemoglobin electrophoresis
You will not qualify if you...
- Diabetes requiring medication
- Hypertension requiring medication
- Sleep disordered breathing requiring treatment
- Body mass index over 40
- Contraindications to MRI such as pacemaker, severe claustrophobia, or pregnancy
- Known systemic inflammatory diseases like inflammatory bowel disease, lupus, 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 heart disease
- No access to a physician to manage iron deficiency anemia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Baseline assessments on Day 0
Participants undergo comprehensive cerebrovascular MRI, bloodwork, patient-reported outcomes, and neurocognitive testing to assess neurocognitive deficits and cerebral physiology related to iron deficiency anemia.
1 baseline visit (in-person)
Duration - Intravenous infusion on Day 0, followed by up to 9 months of daily oral iron therapy
Participants with iron deficiency anemia receive either a single intravenous iron infusion followed by daily oral iron therapy, or standard oral iron therapy managed by their primary care provider.
1 infusion visit and daily oral medication; oral iron therapy managed through routine care
Duration - Up to 1 year post treatment
Participants are assessed at multiple timepoints after iron therapy to evaluate the impact and durability of treatment on brain physiology, neurocognitive function, and patient-reported outcomes.
Visits at Day 14 (IV iron group only), Day 90, Day 180, and Day 365
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
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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