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A Feasibility Trial of Intravenous Iron vs. Oral Iron Supplementation for the Treatment of Postpartum Anemia (IVIRONMAN)
This trial will be a comparative pragmatic open label feasibility randomized controlled trial of oral daily versus IV iron in anemic postpartum patients. Two randomly assigned groups will be compared during the postpartum period: 1. Oral Iron group: Ferrous sulfate 325 mg (65 mg elemental iron) by mouth for a total of 6 weeks TID. IV placebo in sodium chloride 0.9% 500mL IV infusion will be given before discharge home over 1 hour preceded by placebo test dose IV infusion of 100mL 0.9% sodium chloride. 2. IV Iron group: Low molecular weight iron dextran (infed) 1000mg in sodium chloride 0.9% 500mL IV infusion over 1 hour preceded by test dose 25 mg IV low molecular weight iron dextran infusion in 100mL 0.9% sodium chloride. 2.1 Oral placebo will be given by mouth for a total of 6 weeks TID.
Age
18 - 50 years
Sex
FEMALE
Healthy Volunteers
Yes
Ashley Salazar
Galveston, Texas, United States
Start Date
October 7, 2021
Primary Completion Date
March 15, 2023
Completion Date
April 15, 2023
Last Updated
August 29, 2023
40
ACTUAL participants
Ferrous sulfate
DRUG
Iron dextran
DRUG
Lead Sponsor
The University of Texas Medical Branch, Galveston
NCT06411158
NCT05304442
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT06181396