Oral Iron Supplementation on Alternate vs. Consecutive Days for Iron Deficiency Anemia in Pregnancy

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.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy; Iron-deficiency Anemia (IDA)
• Intervention / Treatment: Drug: daily ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill; Drug: alternate day ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill

Detailed Description

During the enrollment (baseline) visit, subjects will undergo a blood draw to assess hemoglobin, ferritin and soluble transferrin receptor (sTfR) levels to confirm current depleted iron stores and will then be randomly allocated into one of the two study arms. All ferrous sulfate (oral tablets) will be provided to patients by the investigators. All subjects will be instructed to take oral iron on an empty stomach or 1 hour after meals for better absorption, preferably with a vitamin C rich product such as orange juice. To minimize variability introduced by other potential iron sources, prenatal vitamins that have the same amount and form of iron will be provided to both study groups.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Kathleen A Groesch, MS; Phone Number: 217-545-6671; Email: kgroesch@siumed.edu
• Study Contact Backup: Name: Teresa S Wilson, BA; Phone Number: 217-545-6711; Email: twilson2@siumed.edu

Study Locations

• United States
  • Illinois
    • Springfield, Illinois, United States, 62702
      • Recruiting
      • Southern Illinois University School of Medicine
      • Contact: Amber Fifer, Pharm D; Phone Number: 217-545-4541; Email: afifer56@siumed.edu
      • Principal Investigator: Yahia Zeino, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Drug: 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; Other Names: daily
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	Drug: 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; Other Names: alternate day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
reversal of iron deficient anemia	hemoglobin > 10.5 g/dL	8 weeks after the baseline visit ± 7 days
reversal of iron deficient anemia	ferritin > 15 mcg/L	8 weeks after the baseline visit ± 7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
soluble transferrin receptor (sTfR) levels within normal range	1.8-4.6 mg/L	8 weeks after the baseline visit ± 7 days

Collaborators and Investigators

• Sponsor: Southern Illinois University
• Investigators: Principal Investigator: Yahia Zeino, MD, Southern Illinois University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 30, 2029

Study Registration Dates

• First Submitted: June 28, 2024
• First Submitted That Met QC Criteria: July 8, 2024
• First Posted (Actual): July 9, 2024

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Iron-deficiency anemia (IDA); Iron-deficiency anemia (IDA) during gestation
• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Anemia; Iron Metabolism Disorders; Anemia, Hypochromic; Nutritional and Metabolic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Anemia, Iron-Deficiency; Physiological Effects of Drugs; Trace Elements; Micronutrients; Iron
• Other Study ID Numbers: 21-924

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No