NCT06492512

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Southern Illinois University · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Iron-deficiency Anemia (IDA)
• Pregnancy

Interventions

Type	Name	Description
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
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

Timeline

• Start date: 2024-12-01
• Primary completion: 2027-07-01
• Completion: 2028-06-30
• First posted: 2024-07-09
• Last updated: 2024-12-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study