Recruiting

Iron Supplementation

Sponsor:

Southern Illinois University

Code:

NCT06492512

Conditions

Iron-deficiency Anemia (IDA)

Pregnancy

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

Interventions

daily ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill

alternate day ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill

Study Details

Brief summary:

This will be a randomized clinical trial. Enrolled subjects will be randomized (1:1) into two study arms to receive either daily (Group 1) or alternate day (Group 2) supplementation with one oral pill containing ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill.

Conditions

Iron-deficiency Anemia (IDA)

Pregnancy

Study ID

NCT06492512

Start date

May 27, 2025

Status verified date

Apr, 2026

Completion date

Jul 30, 2029

Anticipated

Primary completion date

Jul 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Pregnant patients will be enrolled at less than 30 weeks gestational age (GA) with laboratory confirmed IDA (as defined by hemoglobin under 10.5 g/dL, as well as ferritin under 15 mcg/L)

Exclusion Criteria:

  • Patients <18 years old, patients who have severe IDA that requires blood transfusion or IV iron infusion, patients who have other known hemoglobinopathy (such as thalassemia or sickle cell anemia) or anemia of different mechanism (such as vitamin B12 or folate deficiency), patients with ulcerative colitis, Crohn's disease, gastric ulcers, patients who have previously undergone gastric bypass surgery, patients who experience admission for antepartum bleed, have been diagnosed with abnormal placentation (i.e., placenta previa, placenta accreta, placenta increta or percreta)

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 1) Daily dose of ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill

daily (Group 1) supplementation with one oral pill containing ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill

experimental: 2) Alternate daily dose of ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill

alternate day (Group 2) supplementation with one oral pill containing ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill

Interventions

daily ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill

ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill daily

alternate day ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill

ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill every other day

Primary outcome measure

  • reversal of iron deficient anemia [ Time Frame: 8 weeks after the baseline visit ± 7 days ]
  • reversal of iron deficient anemia [ Time Frame: 8 weeks after the baseline visit ± 7 days ]

Central Contacts and Locations

Central contacts

Kathleen A Groesch, MS

217-545-6671kgroesch@siumed.edu

Teresa S Wilson, BA

217-545-6711twilson2@siumed.edu

Locations

Southern Illinois University School of Medicine

Recruiting

Springfield, Illinois, United States, 62702

Contacts

Amber Fifer, Pharm D

217-545-4541afifer56@siumed.edu

Principal Investigator:

Yahia Zeino, MD

More Information

Sponsor

Southern Illinois University

Last update posted

Apr 24, 2026

Last verified

Apr, 2026

Keywords

  • Iron-deficiency anemia (IDA)
  • Iron-deficiency anemia (IDA) during gestation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Southern Illinois University on 2026-04-24.