Iron Replacement Therapy for Iron-Deficiency Anemia
(IDA Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it excludes people who need medication for diabetes or hypertension. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the drug Ferric carboxymaltose for treating iron-deficiency anemia?
Ferric carboxymaltose is effective in treating iron-deficiency anemia, as it replenishes iron stores and corrects anemia in various populations, including those with chronic kidney disease, inflammatory bowel disease, and postpartum anemia. It is generally well tolerated and may require fewer doses compared to other iron treatments, with a lower incidence of gastrointestinal side effects.12345
Is iron replacement therapy safe for humans?
Iron replacement therapy, such as ferric carboxymaltose and ferrous sulfate, is generally safe for humans. However, some people may experience mild side effects like nausea or low phosphate levels in the blood, which are usually temporary and not serious. Ferric carboxymaltose is often better tolerated than oral ferrous sulfate, with fewer stomach-related side effects.12678
What makes ferric carboxymaltose unique for treating iron-deficiency anemia?
Ferric carboxymaltose is unique because it is administered intravenously, allowing for a high dose of iron to be delivered quickly, often in just 15 minutes, which means fewer doses are needed compared to other treatments. It is generally better tolerated than oral iron supplements like ferrous sulfate, with fewer gastrointestinal side effects.12356
What is the purpose of this trial?
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.
Research Team
John Wood, MD,PhD
Principal Investigator
Children's Hospital Los Angeles
Eligibility Criteria
This trial is for adult women aged 18-60 with moderate to severe iron deficiency anemia (IDA). Participants must have specific lab results indicating IDA and a hemoglobin level ≤10.5 g/dl or hematocrit <32%. Exclusions include MRI contraindications, systemic inflammatory diseases, severe asthma, eczema, atopy, diabetes on medication, hypertension on medication, prior reaction to IV iron, severe respiratory/cardiac disease or morbid obesity.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Observation
Comprehensive cerebrovascular MRI, bloodwork, patient-reported outcomes, and neurocognitive testing are collected from all subjects in the observational arm.
Intervention
Eligible anemic subjects receive either intravenous iron therapy or standard oral iron therapy. Repeated tests are conducted to assess the effects and durability of iron therapy.
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments at various time points including Day 14, Day 90, Day 180, and Day 365 post iron therapy.
Treatment Details
Interventions
- Ferric carboxymaltose
- Ferrous sulfate
Ferric carboxymaltose is already approved in European Union, Canada, United States for the following indications:
- Iron deficiency anemia in adult and pediatric patients when oral iron preparations are not tolerated or are ineffective
- Iron deficiency anemia in adult and pediatric patients one year of age and older when oral iron preparations are not tolerated or are ineffective
- Iron deficiency in adult patients with heart failure and New York Heart Association (NYHA) class II/III to improve exercise capacity
- Iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron
Find a Clinic Near You
Who Is Running the Clinical Trial?
Children's Hospital Los Angeles
Lead Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator