Status:
RECRUITING
Oral Iron Supplementation on Alternate Vs. Consecutive Days for Iron Deficiency Anemia in Pregnancy
Lead Sponsor:
Southern Illinois University
Conditions:
Iron-deficiency Anemia (IDA)
Pregnancy
Eligibility:
FEMALE
18-45 years
Phase:
PHASE4
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...
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 wil...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
December 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2028
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06492512
Start Date
December 1 2024
End Date
June 30 2028
Last Update
December 16 2024
Active Locations (1)
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1
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62702