Once Versus Twice Daily Iron Supplementation in Pregnant Women

University of Missouri (MU)

Status: Terminated

Conditions: Anemia in Pregnancy

Treatments: Drug: Ferrous Sulfate; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02839096

2004638

Details and patient eligibility

About

The investigators will randomize women diagnosed with anemia in the mid-trimester of pregnancy to once or twice daily iron supplementation

Full description

Women defined as having iron deficiency anemia based on a low hemoglobin as defined by the American College of Obstetrics and Gynecology and a low serum ferritin, in the absence of hemoglobinopathy, will be randomized to ferrous sulfate 325mg PO daily or PO twice daily.

Enrollment: 20 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Singleton gestation
• Iron deficiency anemia as defined by a Hgb of less than 11mg/dL in the first and 3rd trimester and 10.5mg/dL in the 2nd trimester and a serum ferritin of less than 15ug/mL.
• In accordance with American College of Obstetricians and Gynecologists (ACOG) guidelines, the Hgb cutoff will be reduced by 0.8mg/dL in African American women.
• In accordance with the standard of care, African American women and those with a mean corpuscular volume (MCV) on their routine screening complete blood count (CBC) of less than 70 will require a hemoglobin electrophoresis to exclude hemoglobinopathy prior to enrollment.

Exclusion criteria

• Multiple gestation
• Maternal hemoglobinopathy or hemochromatosis,
• Irritable bowel disease or irritable bowel syndrome
• History of bariatric surgery or extensive bowel surgery
• Individuals already receiving iron supplementation aside from prenatal vitamins.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups

Once Daily Dosing

Other group

Description:

Randomized to 325mg of ferrous sulfate in the morning and placebo in the evening

Treatment:

Drug: Placebo

Drug: Ferrous Sulfate

Twice Daily Dosing

Other group

Description:

Randomized to 325mg of ferrous sulfate in the morning and 325mg of ferrous sulfate in the evening

Treatment:

Drug: Ferrous Sulfate