Once Versus Twice Daily Iron Supplementation in Pregnant Women

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2019-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Anemia in Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

The Clinical Research Unit provides randomization order to the Investigational Pharmacy, which provides treatment or placebo tablets sets to the care provider.

Study Groups

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Once Daily Dosing

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

Group Type OTHER

Placebo

Intervention Type DRUG

Cellulose placebo that will be used in place of a second dose of ferrous sulfate in the subjects randomized to once daily dosing of ferrous sulfate

Ferrous Sulfate

Intervention Type DRUG

Subjects will receive once or twice daily dosing of ferrous sulfate. This will be provided by our hospital pharmacy and be identical in appearance to the placebo.

Twice Daily Dosing

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

Group Type OTHER

Ferrous Sulfate

Intervention Type DRUG

Subjects will receive once or twice daily dosing of ferrous sulfate. This will be provided by our hospital pharmacy and be identical in appearance to the placebo.

Interventions

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Placebo

Cellulose placebo that will be used in place of a second dose of ferrous sulfate in the subjects randomized to once daily dosing of ferrous sulfate

Intervention Type DRUG

Ferrous Sulfate

Subjects will receive once or twice daily dosing of ferrous sulfate. This will be provided by our hospital pharmacy and be identical in appearance to the placebo.

Intervention Type DRUG

Other Intervention Names

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Iron Iron

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes