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

This trial's timeline: 3 weeks for screening, Varies for treatment, and duration of the pregnancy (up to 40 weeks) and up to 2 months postpartum for reporting.

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 more

Secondary 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.

Do I qualify?Apply below to find out