What side effects are associated with this type of intervention?

Common treatments for Iron-Deficiency Anemia, such as intravenous (IV) iron, can cause side effects including gastrointestinal symptoms (nausea, constipation, diarrhea), allergic reactions, and infusion-related reactions like hypotension, dizziness, and headaches. Severe allergic reactions, though rare, can include anaphylaxis. Monitoring during administration is crucial to manage these potential side effects.

What prior FDA approvals exist?

The FDA has approved several intravenous iron formulations for the treatment of Iron-Deficiency Anemia (IDA), particularly in cases where oral iron is ineffective or not tolerated. These include iron sucrose (Venofer), ferric carboxymaltose (Injectafer), and ferumoxytol (Feraheme). These IV iron therapies are designed to rapidly replenish iron stores and improve hemoglobin levels, similar to the treatment being studied in the trial involving pregnant women with moderate-to-severe IDA.

What other types of research exist?

One promising alternative to IV iron for treating iron-deficiency anemia is the use of oral iron supplements with enhanced bioavailability, such as ferric maltol. Additionally, research into hepcidin inhibitors and erythroferrone modulators shows potential in improving iron absorption and utilization. These alternatives aim to provide effective iron replenishment with fewer side effects and greater convenience compared to traditional IV iron therapy.

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Iron Supplement

IV vs Oral Iron for Anemia during Pregnancy (IVIDA2 Trial)

Phase 3

Recruiting

Led By Methodius Tuuli, MD, MPH, MBA

Research Sponsored by Women and Infants Hospital of Rhode Island

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at an average of 6 months and 36 months

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial tests if giving iron through an IV drip can help pregnant women with severe anemia who can't tolerate oral iron. It aims to see if this method reduces the need for blood transfusions and improves baby development.

Who is the study for?

Pregnant women aged 18-45 with moderate-to-severe iron-deficiency anemia, at 24-28 weeks gestation, planning to deliver at a participating hospital. Excluded are those unable to consent or communicate with the team, carrying multiple babies, having certain digestive conditions or sensitivities to iron treatments, and non-iron-related anemias.

What is being tested?

This study is testing if IV iron (Ferric derisomaltose) is more effective and cost-efficient than oral iron (Ferrous sulfate) for pregnant women with low hemoglobin and ferritin levels. It's a double-blind trial meaning neither participants nor researchers know who gets which treatment.

What are the potential side effects?

Possible side effects may include reactions at the injection site for IV iron or gastrointestinal discomfort from oral iron. Each woman's experience can vary; some might have no side effects while others could have more pronounced reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at an average of 6 months and 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at an average of 6 months and 36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and at an average of 6 months and 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Rate of peripartum blood transfusion

Secondary study objectives

Child Mullen Scale of Early Learning Score

Brain

Ferritin

+22 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: IV IronExperimental Treatment1 Intervention

Participants assigned to the IV iron group will receive a single IV infusion of 1000 mg ferric derisomaltose (Monoferric, Pharmacosmos Therapeutics Inc., Morristown, NJ) in 250 mL given over 20 minutes and daily placebo tablets until delivery.

Group II: Oral IronActive Control1 Intervention

Participants assigned to the oral iron group will receive a single 250 mL IV normal saline infusion given over 20 minutes and 325mg tablets of ferrous sulfate (65 mg of elemental iron) to be taken until delivery.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Iron-Deficiency Anemia (IDA) include oral and intravenous (IV) iron supplementation. Oral iron supplements, such as ferrous sulfate, ferrous gluconate, and ferrous fumarate, work by providing elemental iron that is absorbed in the intestines to increase iron levels. However, they can cause gastrointestinal side effects and may be less effective in cases of severe deficiency or malabsorption. IV iron is administered directly into the bloodstream, allowing for rapid replenishment of iron stores, making it particularly beneficial for patients with severe IDA, those who cannot tolerate oral iron, or those needing a quick increase in iron levels. These treatments are crucial for improving hemoglobin levels and overall iron status, which is essential for the effective management of IDA.