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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

IVIDA2 Trial Summary

This trial tests if giving iron to pregnant women with low iron levels will improve the health of both the mother and child.

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.Check my eligibility
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.See study design
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.

IVIDA2 Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of peripartum blood transfusion
Secondary outcome measures
Child Mullen Scale of Early Learning Score
Brain
Ferritin
+22 more

IVIDA2 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.

Find a Location

Who is running the clinical trial?

Women and Infants Hospital of Rhode IslandLead Sponsor
109 Previous Clinical Trials
37,854 Total Patients Enrolled
Hasbro Children's HospitalOTHER
4 Previous Clinical Trials
9,310 Total Patients Enrolled
University of MichiganOTHER
1,797 Previous Clinical Trials
6,377,312 Total Patients Enrolled

Media Library

Ferric derisomaltose (Iron Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT05462704 — Phase 3
Iron-Deficiency Anemia Research Study Groups: IV Iron, Oral Iron
Iron-Deficiency Anemia Clinical Trial 2023: Ferric derisomaltose Highlights & Side Effects. Trial Name: NCT05462704 — Phase 3
Ferric derisomaltose (Iron Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05462704 — Phase 3
Iron-Deficiency Anemia Patient Testimony for trial: Trial Name: NCT05462704 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any more slots open for participants in this experiment?

"No, this study is not recruiting patients at the moment. The trial was first announced on August 1st, 2022 and was most recently updated over a month ago on July 14th, 2022. Although this particular study isn't looking for new participants, there are 350 other trials that are currently enrolling patients."

Answered by AI

Could you detail any potential health concerns associated with Ferric derisomaltose?

"Ferric derisomaltose has undergone Phase 3 clinical trials, meaning that there is both supportive efficacy data as well as multiple rounds of safety testing. Consequently, it receives a score of 3 for safety."

Answered by AI

How can I become a test subject for this experiment?

"The requirements for this clinical trial are that participants must have iron deficiency anemia and be between 18-45 years old. Up to 746 patients will be accepted into the study."

Answered by AI

Are people who are middle-aged applicable for this treatment program?

"The18-45 age bracket is a requirement for eligibility in this trial. There are 127 other studies available for patients that are younger and 222 for those who are older."

Answered by AI

Who else is applying?

What state do they live in?
Massachusetts
What site did they apply to?
Women & Infants Hospital of Rhode Island
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

I've been told twice so far during this pregnancy my iron level is low.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

when / how often need to physically visit particular hospital?
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Intravenous Versus Oral Iron for Treating Iron-Deficiency Anemia in Pregnancy
Methodius Tuuli 2023. "Intravenous Versus Oral Iron for Treating Iron-Deficiency Anemia in Pregnancy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05462704.
~497 spots leftby Mar 2027
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