Daily Versus Alternate Day Iron Supplementation for the Treatment of Iron Deficiency Anemia in Pregnancy
Purpose
The target population for our study is pregnant women in the first or second trimester with a diagnosis of iron deficiency anemia. If a subject is eligible, written consent will be obtained by person to person contact. Eligible participants will be randomized to receive either daily oral iron supplementation or every other day oral iron supplementation.
Conditions
- Pregnancy Related
- Iron Deficiency Anemia of Pregnancy
Eligibility
- Eligible Ages
- Between 18 Years and 50 Years
- Eligible Genders
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Hemoglobin less than 11 g/dl in the first trimester or less than 10.5 g/dl in the second trimester - Microcytic anemia - Singleton gestation in the first or second trimester
Exclusion Criteria
- Malabsorptive disorder or history of restrictive or malabsorptive gastric surgery - Known diagnosis of anemia other than iron deficiency (thalassemia, macrocytic, sickle cell, etc.) - History of cardiopulmonary disease - Severe anemia requiring parental infusion or transfusion of blood products
Study Design
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Daily iron supplementation |
Oral ferrous sulfate, 325 mg, take once daily |
|
|
Experimental Alternate day iron supplementation |
Oral ferrous sulfated, 650mg, taken once daily every other day |
|
More Details
- Status
- Terminated
- Sponsor
- The University of Texas Medical Branch, Galveston
Study Contact
Detailed Description
Eligible pregnant women in the first or second trimester who carry a diagnosis of iron deficiency anemia as defined by the American College of Obstetrics and Gynecology will be approached, consented, and randomized to receive either daily oral ferrous sulfate (325mg) supplementation or every other day oral ferrous sulfate (650mg). Participants will undergo a phone survey 2-4 weeks after starting the study to assess for side effects. Participants will continue routine care and surveillance of iron deficiency in pregnancy until the end of pregnancy.