NCT05929729 Iron Deficiency Anemia (IDA) and the Brain
| NCT ID | NCT05929729 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Children's Hospital Los Angeles |
| Condition | IDA - Iron Deficiency Anemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2023-12-07 |
| Primary Completion | 2028-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 120 participants in total. It began in 2023-12-07 with a primary completion date of 2028-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Observational arm: 1. Age between 16 and 60 years of age. 2. Any ethnicity. 3. Female 4. Anemic group: hemoglobin ≤10.5 g/dl or hematocrit \<32% from finger prick or plethysmography test, or \<11 g/dl from venipuncture blood draw 5. Control group: hemoglobin \>13.2 g/dl or hematocrit \>39.6% * Interventional arm: 1. Criteria for observational component, plus 2. Iron deficiency anemia based upon attending hematologist interpretation of transferrin saturation, ferritin, and other ancillary labs including hs-CRP, MMA, hemoglobin electrophoresis Exclusion Criteria: * Observational arm: 1. Diabetes requiring medication. 2. Hypertension requiring medication. 3. Sleep disordered breathing requiring intervention. 4. Body mass index \>40 (morbid obesity) 5. Contraindications to MRI, including pacemaker, severe claustrophobia, pregnancy. 6. Known systemic inflammatory disease such as inflammatory bowel disease, systemic lupus erythematosus, or scleroderma. 7. Known HIV. * Interventional arm: 1. Criteria for observational component, plus 2. Prior reaction to intravenous iron. 3. History of multiple drug allergies. 4. History of severe asthma, eczema, or atopy. 5. Systemic mastocytosis. 6. Severe respiratory or cardiac disease. 7. Having no access to a physician who can manage the iron deficiency anemia.
Contact & Investigator
John Wood, MD, PhD
PRINCIPAL INVESTIGATOR
Children's Hospital Los Angeles
Frequently Asked Questions
Who can join the NCT05929729 clinical trial?
This trial is open to female participants only, aged 16 Years or older, up to 60 Years, studying IDA - Iron Deficiency Anemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05929729 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05929729 currently recruiting?
Yes, NCT05929729 is actively recruiting participants. Contact the research team at anemia@chla.usc.edu for enrollment information.
Where is the NCT05929729 trial being conducted?
This trial is being conducted at Duarte, United States, Los Angeles, United States, Los Angeles, United States, Los Angeles, United States.
Who is sponsoring the NCT05929729 clinical trial?
NCT05929729 is sponsored by Children's Hospital Los Angeles. The principal investigator is John Wood, MD, PhD at Children's Hospital Los Angeles. The trial plans to enroll 120 participants.