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Intermittent vs Daily Oral Iron for Anemia in Pregnancy
NCT04594070Phase 4
Key facts
- Status
- Terminated
- Start
- Oct 2020
- Primary completion
- Jan 2024
- Countries
- 1
- Sponsor
- The University of Texas Medical Branch at Galveston
- Modality
- Small Molecules
- Drugs
- ferrous sulfate
- Conditions
- iron deficiency anemia (IDA)
01
Overview
Phase 4, randomised, open-label trial of ferrous sulfate in iron deficiency anemia (IDA) (2 arms), sponsored by The University of Texas Medical Branch at Galveston. Primary endpoints: Difference in Hemoglobin Levels From Enrollment to End of Study and Change in Hematocrit in the Third Trimester After Treatment. Started Oct 2020; status: terminated.
02
Design
2 arms- Study design
- RandomizedOpen-label
Daily iron supplementation
Oral ferrous sulfate, 325 mg, take once daily
Alternate day iron supplementation
Oral ferrous sulfate, 650mg, taken once daily every other day
03
Endpoints
Primary
Difference in Hemoglobin Levels From Enrollment to End of Study
Change in Hematocrit in the Third Trimester After Treatment
Secondary
Gastrointestinal Side Effects After 2-4 Weeks of Treatment
Complete Blood Count in the Third Trimester
Serum Ferritin at Time of Enrollment
Total Iron Binding Capacity at Time of Enrollment
Transferrin at Time of Enrollment
Number of Participants Who Receive Intravenous (IV) Iron Supplementation
Number of Participants Who Receive a Blood Transfusion
Postpartum Hemoglobin
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