Oral Iron Supplementation on Alternate vs. Consecutive Days for Iron Deficiency Anemia in Pregnancy
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorSouthern Illinois University
About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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)
Trial design
Treatments tested in this trial
- daily 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
Treatment groups
120 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov