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

Phase 4

Recruiting

• Conditions: Pregnancy; Iron-deficiency Anemia (IDA)
• Interventions: 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

• Registration Number: NCT06492512
• Lead Sponsor: Southern Illinois University

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.

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 Timeline

• Study First Submitted: 2024-06-28
• Status Verified: 2024-07
• Study First Submitted QC: 2024-07-08
• Study First Posted: 2024-07-09
• Study Start: 2024-12
• Last Update Submitted: 2024-12-10
• Last Update Posted: 2024-12-16
• Primary Completion: 2027-07-01
• Study Completion: 2028-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1) Daily dose of ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill	daily 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
2) Alternate 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	alternate day (Group 2) supplementation with one oral pill containing ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill

Primary Outcome Measures

Name	Time	Method
reversal of iron deficient anemia	8 weeks after the baseline visit ± 7 days	ferritin \> 15 mcg/L

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Southern Illinois University School of Medicine; 🇺🇸 Springfield, Illinois, United States