Anemia, Iron Deficiency Clinical Trial
— IVIRONMANOfficial title:
A Feasibility Trial of Intravenous Iron vs. Oral Iron Supplementation for the Treatment of Postpartum Anemia (IVIRONMAN)
Verified date | August 2023 |
Source | The University of Texas Medical Branch, Galveston |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | April 15, 2023 |
Est. primary completion date | March 15, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility | Inclusion Criteria: - Delivery at our institution - Hemoglobin below 9 g/dl in postpartum day 1 - Singleton gestation Exclusion Criteria: - Diagnosis of malabsorptive disorder or history of gastric bypass procedure - Known diagnosis of anemia other than iron deficiency (thalassemia, macrocytic anemia, sickle cell, etc.) - Significant cardiovascular disease, including but not limited to myocardial infarction or unstable angina within 6 months prior to study inclusion or current history of NYHA Class III or IV congestive heart failure - Patient has received blood transfusion or there is a plan to transfuse - Lactose intolerance |
Country | Name | City | State |
---|---|---|---|
United States | Ashley Salazar | Galveston | Texas |
Lead Sponsor | Collaborator |
---|---|
The University of Texas Medical Branch, Galveston |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hemoglobin Level | hemoglobin in grams per deciliters | 6 weeks after delivery | |
Secondary | Number of Participants With Nausea or Vomiting | feeling sick to vomit or vomit | up to 6 weeks after delivery | |
Secondary | Myalgia | Generalized muscle pain | up to 6 weeks after delivery |
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