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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 belowSelect...
My blood tests show I have low hemoglobin or hematocrit levels.
Select...
I am a woman.
Select...
I am between 18 and 60 years old.
IDA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 14 (for iv iron group only), day 90, day 180, day 365
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 14 (for iv iron group only), day 90, day 180, day 365
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 moreSecondary 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 moreIDA 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.
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Who is running the clinical trial?
Children's Hospital Los AngelesLead Sponsor
232 Previous Clinical Trials
5,076,632 Total Patients Enrolled
3 Trials studying Anemia
190 Patients Enrolled for Anemia
John Wood, MD, PhDPrincipal InvestigatorChildren's Hospital Los Angeles
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- In the observational group, the control group should have hemoglobin levels above 13.2 g/dl or hematocrit levels above 39.6%.I had a reaction to intravenous iron in the past.I am taking medication for high blood pressure.My blood tests show I have low hemoglobin or hematocrit levels.I have severe heart or lung disease.I need treatment for my sleep-related breathing problem.My BMI is over 40, indicating morbid obesity.I have a known inflammatory disease like IBD, lupus, or scleroderma.I have iron deficiency anemia as diagnosed by a hematologist.I have been diagnosed with systemic mastocytosis.You have a history of being allergic to many different medications.If you have HIV, you cannot participate in this part of the study.I am a woman.You cannot have an MRI because you have a pacemaker, extreme fear of small spaces, or you are pregnant.You have a history of severe asthma, eczema, or allergies.I have diabetes and take medication for it.I don't have a doctor to treat my iron deficiency anemia.I am between 18 and 60 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of care iron
- Group 2: Intravenous (IV) iron
- Group 3: Healthy Controls
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are adults of legal age being admitted into this clinical trial?
"This research is looking for individuals between 16 and 60 years of age."
Answered by AI
Are there any risks associated with intravenous iron treatments?
"There is ample empirical evidence of IV iron's safety, which secures it a score of 3."
Answered by AI
Is enrollment for this experiment still available?
"In order to qualify for this clinical trial, patients must suffer from anemia and be between the ages of 16 and 60. The total number of participants in the study is 96."
Answered by AI
Are there still spots available for participants in this experiment?
"Examining the latest information hosted on clinicaltrials.gov, it appears that no further candidates are being sought for this study; its first posting was July 1st 2023 and last update was June 16th 2023. Despite this, there are still 257 other trials actively recruiting patients at present."
Answered by AI
What are the fundamental aims of this research endeavor?
"The primary end-point of this clinical trial, which will be monitored for 90 days, is to measure the impact of iron therapy on regional cerebrovascular oxygen delivery. Other objectives include evaluating patient reported outcomes such as fatigue and quality of life through functional assessment tests and Rand Short Form Health Surveys post treatment respectively. Additionally, MRI measurements can be used to assess brain iron levels in deep nuclei regions like hippocampus and grey/white matter areas."
Answered by AI
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