Your session is about to expire
← Back to Search
Iron Supplement
Intravenous vs Oral Iron for Anemia (IDA Trial)
Phase 3
Recruiting
Research Sponsored by Arrowhead Regional Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up duration of the pregnancy (up to 40 weeks) and up to 2 months postpartum
Awards & highlights
Pivotal Trial
Summary
This trial aims to see if giving pregnant women with low iron levels intravenous iron early in pregnancy is better than the standard oral iron treatment. Women with low iron levels were randomly given either oral or intr
Who is the study for?
This trial is for pregnant individuals with iron deficiency anemia. Participants must have a confirmed diagnosis and be at a stage in their pregnancy where they can safely receive treatment. There's no mention of specific exclusion criteria provided, so it's unclear who might not qualify.
What is being tested?
The study compares two ways to treat iron deficiency anemia in pregnancy: one group receives Venofer (an intravenous iron injection), while the other takes Ferrous sulfate (oral iron tablets). Patients are randomly chosen for either method and monitored over time to see which is more effective.
What are the potential side effects?
Potential side effects of Venofer may include taste changes, dizziness, high blood pressure, or pain at the injection site. Oral Ferrous sulfate could cause stomach upset, constipation, diarrhea, or dark stools.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ duration of the pregnancy (up to 40 weeks) and up to 2 months postpartum
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~duration of the pregnancy (up to 40 weeks) and up to 2 months postpartum
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Delivery Hemoglobin
Ferritin difference
Hemoglobin difference
+2 moreSecondary study objectives
Birthweight
Depression
Preterm delivery
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Intravenous ironActive Control1 Intervention
Venofer 200 mg will be given every other day until the patient reaches their calculated in deficit dose. The does of IV iron will be calculated according to the Ganzoni formula: total iron dose (mg) = body weight (kg) x (target Hgb - baseline Hgb (g/dL)) × 0.24 + 500 mg.14 Our target Hgb will be 11.0 g/dL. The determination of the treatment duration and dosage will be based on the calculation of the iron deficit.
Group II: Oral ironPlacebo Group1 Intervention
Ferrous sulfate 325 mg orally every other day on an empty stomach with lemon/orange water until delivery.
Find a Location
Who is running the clinical trial?
Arrowhead Regional Medical CenterLead Sponsor
16 Previous Clinical Trials
26,815 Total Patients Enrolled