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Iron Supplement

Iron dextran for Iron-Deficiency Anemia (IVIRONMAN Trial)

Phase 4
Waitlist Available
Research Sponsored by The University of Texas Medical Branch, Galveston
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 up to 6 weeks after delivery
Awards & highlights
Approved for 10 Other Conditions
Pivotal Trial
All Individual Drugs Already Approved
Drug Has Already Been Approved
No Placebo-Only Group

Summary

This trial compares two methods of giving iron to new mothers with low iron levels after childbirth. One group will take iron pills, while the other will receive iron through an IV drip. The goal is to see which method is more effective at increasing red blood cells and improving recovery. Previous studies have shown that receiving iron through an IV can be more effective than taking iron pills.

Eligible Conditions
  • Iron-Deficiency Anemia
  • Delivery Complications

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks after delivery
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks after delivery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Hemoglobin Level
Secondary study objectives
Myalgia
Number of Participants With Nausea or Vomiting

Side effects data

From 2019 Phase 4 trial • 38 Patients • NCT03438227
30%
Constipation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Intravenous Iron Dextran Infusion
Oral Ferrous Sulfate Supplementation

Awards & Highlights

Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: IV Iron groupExperimental Treatment1 Intervention
Low molecular weight iron dextran (infed) 1000mg in sodium chloride 0.9% 500mL IV infusion over 1 hour preceded by test dose 25 mg IV low molecular weight iron dextran infusion in 100mL 0.9% sodium chloride. Oral placebo will be given by mouth for a total of 6 weeks TID.
Group II: Oral Iron groupActive Control1 Intervention
Ferrous sulfate 325 mg (65 mg elemental iron) by mouth for a total of 6 weeks three times daily. Intravenous placebo in sodium chloride 0.9% 500mL IV infusion will be given before discharge home over 1 hour preceded by placebo test dose IV infusion of 100mL 0.9% sodium chloride.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Iron Dextran
FDA approved

Find a Location

Who is running the clinical trial?

The University of Texas Medical Branch, GalvestonLead Sponsor
252 Previous Clinical Trials
56,846 Total Patients Enrolled
~10 spots leftby Dec 2025
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