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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

IVIRONMAN Trial Summary

This trial will compare the feasibility and effectiveness of oral versus IV iron in anemic postpartum patients.

Eligible Conditions
  • Iron-Deficiency Anemia
  • Delivery Complications

IVIRONMAN Trial Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Hemoglobin Level
Secondary outcome measures
Myalgia
Number of Participants With Nausea or Vomiting

IVIRONMAN 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
241 Previous Clinical Trials
56,558 Total Patients Enrolled

Frequently Asked Questions

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

How many participants can this trial include?

"Affirmative. Clinicaltrials.gov states that the research study, initiated on October 7th 2021, is still in its enrollment phase and needs 40 participants from a single site."

Answered by AI

Who is the intended audience for this clinical experiment?

"Patients aged 18 to 50 with iron deficiency anemia can apply for this clinical trial. As of now, 40 individuals are needed as participants in the study."

Answered by AI

In what ways is Iron dextran routinely employed?

"Iron dextran is frequently prescribed to breast feeding mothers, but it can also be utilized in the treatment of folic acid deficiency and dietary iron supplementation."

Answered by AI

Are there any available openings for participants in this clinical trial?

"The information housed on clinicaltrials.gov reveals that this medical trial is currently open for participant recruitment. It was initially posted to the database on October 7th 2021, and has since been updated as of the same date."

Answered by AI

Have any further examinations of Iron dextran been conducted beyond this trial?

"Presently, there are 26 clinical trials studying Iron dextran with 6 of those in the advanced Phase 3 stage. While Kano and Lagos host many studies for this medication, a total of 140 sites across the globe have enrolled patients into these investigations."

Answered by AI

How does Iron dextran impact a person's safety?

"Iron dextran has been approved, suggesting that its safety is high. Thus, it was assigned a score of 3 by the Power team."

Answered by AI

Are individuals aged over 35 being recruited for participation in this experiment?

"As outlined by the requirements for this medical trial, only those aged 18 to 50 can apply."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Intravenous Iron vs. Oral Iron Supplementation for Postpartum Anemia
2021. "Intravenous Iron vs. Oral Iron Supplementation for Postpartum Anemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05047211.
~11 spots leftby Apr 2025
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