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Iron Supplement

Iron Supplementation for Iron-Deficiency Anemia

Phase 4
Waitlist Available
Led By Yahia Zeino, MD
Research Sponsored by Southern Illinois University
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
Must not have
Patients under 18 years old
Patients with severe IDA requiring blood transfusion or IV iron infusion
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks after the baseline visit ± 7 days
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial will randomly assign participants into two groups. One group will take a daily iron supplement pill, while the other group will take the same pill every other day. Each pill contains 65 mg of

Who is the study for?
This trial is for pregnant individuals diagnosed with iron deficiency anemia. Participants should be willing to take oral iron supplements and have no health conditions that would interfere with the study.
What is being tested?
The study is testing if taking iron pills every other day (Group 2) is as effective as taking them daily (Group 1) in treating anemia during pregnancy. Each participant will receive a pill containing ferrous sulfate, providing 65 mg of elemental iron.
What are the potential side effects?
Common side effects of oral iron supplements include stomach upset, constipation, diarrhea, nausea, and dark stools. These may vary based on the frequency of supplementation.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am under 18 years old.
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I need a blood transfusion or IV iron for my severe iron deficiency anemia.
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I have ulcerative colitis, Crohn's disease, or gastric ulcers.
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I have a condition like thalassemia or sickle cell anemia, or my anemia is caused by vitamin deficiencies.
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I have had gastric bypass surgery in the past.
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I have been diagnosed with a placental condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks after the baseline visit ± 7 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks after the baseline visit ± 7 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
reversal of iron deficient anemia
Secondary study objectives
soluble transferrin receptor (sTfR) levels within normal range

Awards & Highlights

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

Trial Design

2Treatment groups
Experimental Treatment
Group I: 2) Alternate daily dose of ferrous sulfate with an equivalent elemental iron dose of 65 mg per pillExperimental Treatment1 Intervention
alternate day (Group 2) supplementation with one oral pill containing ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill
Group II: 1) Daily dose of ferrous sulfate with an equivalent elemental iron dose of 65 mg per pillExperimental Treatment1 Intervention
daily (Group 1) supplementation with one oral pill containing ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill

Find a Location

Who is running the clinical trial?

Southern Illinois UniversityLead Sponsor
38 Previous Clinical Trials
16,126 Total Patients Enrolled
Yahia Zeino, MDPrincipal InvestigatorSouthern Illinois University School of Medicine
~80 spots leftby Apr 2027
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