Daily Versus Alternate Day Iron Supplementation for the Treatment of Iron Deficiency Anemia in Pregnancy

The University of Texas System (UT)

Status and phase: Terminated; Phase 4

Conditions: Pregnancy Related; Iron Deficiency Anemia of Pregnancy

Treatments: Drug: Ferrous sulfate

Study type: Interventional

Funder types: Other

Identifiers

NCT04594070

20-0068

Details and patient eligibility

About

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.

Full 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.

Enrollment: 14 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

Daily iron supplementation

Active Comparator group

Description:

Oral ferrous sulfate, 325 mg, take once daily

Treatment:

Drug: Ferrous sulfate

Alternate day iron supplementation

Experimental group

Description:

Oral ferrous sulfated, 650mg, taken once daily every other day

Treatment:

Drug: Ferrous sulfate