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

NCT06492512 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 21-924
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• soluble transferrin receptor (sTfR) levels within normal range

  8 weeks after the baseline visit ± 7 days

Study Arms (2)

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

Interventions

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

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

Also known as: daily

1) Daily dose of 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 DRUG

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

Also known as: alternate day

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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: pregnant women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Southern Illinois University: lead

Study Sites (1)

Southern Illinois University School of Medicine

Springfield, Illinois, 62702, United States

RECRUITING

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Yahia Zeino, MD

  Southern Illinois University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathleen A Groesch, MS

CONTACT

217-545-6671; kgroesch@siumed.edu

Teresa S Wilson, BA

CONTACT

217-545-6711; twilson2@siumed.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized 1:1 for daily iron (ferrous sulfate) supplementation vs. every other day iron (ferrous sulfate) supplementation

Study Record Dates

• First Submitted: June 28, 2024
• First Posted: July 9, 2024
• Study Start: May 27, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 30, 2029
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)