Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06492512

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Southern Illinois University School of Medicine

Springfield, Illinois, 62702, United States

Location status: Recruiting

Location contact

Amber Fifer, Pharm D

CONTACT

[email protected]

217-545-4541

Yahia Zeino, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Other names: daily

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

Other names: alternate day

Primary outcomes

  1. reversal of iron deficient anemia

    Time frame: 8 weeks after the baseline visit ± 7 days

    hemoglobin > 10.5 g/dL

  2. reversal of iron deficient anemia

    Time frame: 8 weeks after the baseline visit ± 7 days

    ferritin > 15 mcg/L

Secondary outcomes

  1. soluble transferrin receptor (sTfR) levels within normal range

    Time frame: 8 weeks after the baseline visit ± 7 days

    1.8-4.6 mg/L

Study contacts

Contact information is provided by the study sponsor or research team.

Kathleen A Groesch, MS

CONTACT

[email protected]

217-545-6671

Teresa S Wilson, BA

CONTACT

[email protected]

217-545-6711

Sponsors and collaborators

Lead sponsor

Southern Illinois University

Other

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Jul 9, 2024
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.