Once Versus Twice Daily Iron Supplementation in Pregnant Women

Sponsor

University of Missouri-Columbia (Other)

Overall Status

Unknown status

CT.gov ID

NCT02839096

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Anemia in Pregnancy	Drug: Placebo Drug: Ferrous Sulfate	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Once Daily Versus Twice Daily Iron Supplementation to Treat Anemia in Pregnancy: A Prospective, Randomized, Placebo Controlled, Double Blinded, Clinical Trial

Study Start Date :

Jun 1, 2016

Anticipated Primary Completion Date :

Jun 1, 2019

Anticipated Study Completion Date :

Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Other: Once Daily Dosing Randomized to 325mg of ferrous sulfate in the morning and placebo in the evening	Drug: 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 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.
Other: Twice Daily Dosing Randomized to 325mg of ferrous sulfate in the morning and 325mg of ferrous sulfate in the evening	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.

Arm

Intervention/Treatment

Other: Once Daily Dosing

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

Drug: 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

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.

Other: Twice Daily Dosing

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

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.

Outcome Measures

Primary Outcome Measures

Hemoglobin [Change in hemoglobin from baseline to one day postpartum]
Maternal Hemoglobin will be measured at baseline, at the time of admission for labor and delivery and on post partum day one
Incidence of gastrointestinal side effects (i.e. constipation, upset stomach) as measured by a validated questionaire [From enrollment to delivery, which will be an average of 10-12 weeks]
Gastrointestinal side effects (i.e. constipation, upset stomach) as measured by a validated questionaire

Secondary Outcome Measures

Incidence of blood transfusion at delivery [At delivery]
The number of units of blood product transfused during the admission for delivery will be recorded

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Missouri	Columbia	Missouri	United States	65212

Sponsors and Collaborators

University of Missouri-Columbia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Daniel Lee Jackson, Assistant Professor, University of Missouri-Columbia

ClinicalTrials.gov Identifier:

NCT02839096

Other Study ID Numbers:

2004638

First Posted:

Jul 20, 2016

Last Update Posted:

Apr 18, 2019

Last Verified:

Apr 1, 2019

Additional relevant MeSH terms:

Anemia

Study Results

No Results Posted as of Apr 18, 2019