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Iron Supplement

Iron Replacement Therapy for Iron-Deficiency Anemia (IDA Trial)

Phase 4
Waitlist Available
Led By John Wood, MD, PhD
Research Sponsored by Children's Hospital Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Observational arm: Anemic group: hemoglobin ≤10.5 g/dl or hematocrit <32% from finger prick or plethysmography test, or <11 g/dl from venipuncture blood draw
Observational arm: Female
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 14 (for iv iron group only), day 90, day 180, day 365
Awards & highlights

IDA Trial Summary

This trial studies the effects of iron deficiency anemia on adult women's cognition, brain blood flow, and brain function, and the reversibility of effects with iron replacement therapy.

Who is the study for?
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.Check my eligibility
What is being tested?
The study aims to understand the impact of IDA on brain function and structure in women and test if these effects can be reversed by iron replacement therapy. It involves two treatments: NovaFerrum and Ferric derisomaltose. The trial has both observational (examining existing conditions) and interventional (testing new treatments) components.See study design
What are the potential side effects?
Potential side effects from the interventions may include allergic reactions like itching or rash; gastrointestinal issues such as nausea or constipation; headaches; dizziness; muscle cramps; infusion-related reactions including low blood pressure or fever.

IDA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My blood tests show I have low hemoglobin or hematocrit levels.
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I am a woman.
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I am between 18 and 60 years old.

IDA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 14 (for iv iron group only), day 90, day 180, day 365
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 14 (for iv iron group only), day 90, day 180, day 365 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Impact of iron deficiency anemia on blood brain barrier permeability surface area product (ml H20/100g/min)
Impact of iron deficiency anemia on cerebral metabolic rate of oxygen (ml O2/100g/min).
Impact of iron deficiency anemia on cerebrovascular flow reactivity (%SI change/%ETCO2)
+34 more
Secondary outcome measures
Acute impact of intravenous (IV) iron therapy on list learning and recall task in people with iron deficiency anemia.
Acute impact of intravenous (IV) iron therapy on visuospatial memory in people with iron deficiency anemia.
Changes in Restless Legs Syndrome (RLS) as an effect of iron therapy in people with iron deficiency anemia will be assessed post iron therapy.
+8 more

IDA Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Intravenous (IV) ironExperimental Treatment2 Interventions
This group will receive intravenous iron (Ferric Derisomaltose) in a single dose of 20 mg/kg (max individual dose of 1000 mg). The drug is administered as an infusion over 30 minutes. 3 months after the infusion, they will receive a 9-month supply of Novaferrum pill to be taken once a day.
Group II: Standard of care ironActive Control1 Intervention
This group will be referred to their primary care provider for oral iron therapy. If a participant cannot obtain care from a physician
Group III: Healthy ControlsActive Control1 Intervention
This group will only be participating in the observational part of the study and serve as our controls.

Find a Location

Who is running the clinical trial?

Children's Hospital Los AngelesLead Sponsor
236 Previous Clinical Trials
5,076,960 Total Patients Enrolled
3 Trials studying Anemia
190 Patients Enrolled for Anemia
John Wood, MD, PhDPrincipal InvestigatorChildren's Hospital Los Angeles

Media Library

Ferric carboxymaltose (Iron Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT05929729 — Phase 4
Anemia Research Study Groups: Standard of care iron, Intravenous (IV) iron, Healthy Controls
Anemia Clinical Trial 2023: Ferric carboxymaltose Highlights & Side Effects. Trial Name: NCT05929729 — Phase 4
Ferric carboxymaltose (Iron Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05929729 — Phase 4
~91 spots leftby Sep 2028
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