Iron Replacement Therapy for Iron-Deficiency Anemia
(IDA Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to explore how iron deficiency anemia (IDA) affects the brain and whether iron replacement can enhance brain function and blood flow in adult women with moderate to severe anemia. It will assess two treatments: standard oral iron supplements (ferrous sulfate) and an intravenous iron infusion (ferric carboxymaltose) followed by a daily iron pill. Women who have struggled with anemia and experience symptoms like fatigue might be suitable for the interventional arm. Those with normal iron levels can join as healthy controls for the observational part.
As a Phase 4 trial, the treatment is already FDA-approved and proven effective, aiming to understand how it benefits more patients.
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 is the safety track record for Ferric carboxymaltose and Ferrous sulfate?
Research shows that ferric carboxymaltose, one of the treatments under study, is generally safe and well-tolerated. Studies have found that it effectively raises hemoglobin levels with only a few minor side effects. Most patients experienced minimal adverse reactions. Ferrous sulfate, another treatment, is a common and FDA-approved option for iron deficiency anemia. It is generally safe, though some people might experience mild digestive issues like stomach upset or constipation. Overall, these treatments have undergone sufficient testing to demonstrate their safety for most people.12345
Why are researchers enthusiastic about this study treatment?
Unlike traditional oral iron supplements like ferrous sulfate, which can take weeks to improve symptoms of iron-deficiency anemia and sometimes cause digestive side effects, ferric carboxymaltose offers a different approach. Researchers are excited about ferric carboxymaltose because it's administered intravenously, allowing for a higher dosage to be delivered directly into the bloodstream, which can replenish iron stores more rapidly. This method potentially leads to quicker symptom relief and is especially beneficial for those who can't tolerate or absorb oral iron well.
What evidence suggests that this trial's treatments could be effective for iron-deficiency anemia?
Research has shown that ferric carboxymaltose, which participants in this trial may receive as part of the intravenous (IV) iron treatment arm, effectively treats iron-deficiency anemia (IDA). Studies have found that it improves hemoglobin and ferritin levels, which are crucial for oxygen transport in the blood. In one study, a single dose of ferric carboxymaltose was safe and often outperformed other iron treatments. Another study found it more effective than iron pills, particularly in correcting anemia and iron deficiency. This treatment has successfully managed IDA in various patient groups, demonstrating its effectiveness.678910
Who Is on the Research Team?
John Wood, MD,PhD
Principal Investigator
Children's Hospital Los Angeles
Are You a Good Fit for This Trial?
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 for a Trial Participant
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.
What Are the Treatments Tested in This Trial?
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