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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks after delivery

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%

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

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