Once Versus Twice Daily Iron Supplementation in Pregnant Women

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

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

Study Overview

• Status: Terminated
• Conditions: Anemia in Pregnancy
• Intervention / Treatment: Drug: Placebo; Drug: Ferrous Sulfate

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Columbia, Missouri, United States, 65212
      • University of Missouri

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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; Other Names: Iron; 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 Names: Iron
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.; Other Names: Iron

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin	Maternal Hemoglobin will be measured at baseline, at the time of admission for labor and delivery and on post partum day one. Postpartum day 1 hemoglobin was estimated from hematocrit by dividing by 2.941.	Change in hemoglobin from baseline to one day postpartum
Incidence of Gastrointestinal Side Effects (i.e. Constipation, Upset Stomach) as Measured by a Validated Questionnaire	Record the incidence of gastrointestinal side effects (i.e. constipation, upset stomach) as measured by a validated questionnaire.	From enrollment to delivery, which will be an average of 10-12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Blood Transfusion at Delivery	The number of patients who received a blood product transfusion at delivery.	At delivery

Collaborators and Investigators

• Sponsor: University of Missouri-Columbia
• Investigators: Principal Investigator: Mistie P Mills, MD, University of Missouri-Columbia

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: June 9, 2016
• First Submitted That Met QC Criteria: July 19, 2016
• First Posted (Estimated): July 20, 2016

Study Record Updates

• Last Update Posted (Actual): September 19, 2024
• Last Update Submitted That Met QC Criteria: August 21, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia; Physiological Effects of Drugs; Trace Elements; Micronutrients; Iron
• Other Study ID Numbers: 2004638

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The final dataset will include (1) demographics, (2) baseline/postpartum hematocrit and levels of hemoglobin, ferritin and hepcidin, and (3) clinical data related to the pregnancy and outcomes. Protected personal information will be removed by trained staff at the Ob/Gyn Clinical Research Unit according to HIPAA guidelines. The final dataset will identify participants by a study number and dates will be replaced by time intervals. Data release is restricted to users under a data-transfer agreement (DTA) that provides for (1) a commitment to using the data only for research purposes and not to seek to identify any individual participant; (2) restrictions on redistribution of data to third parties, (3) a commitment to securing data using appropriate computer technology; and (4) a commitment to destroying or returning the data after analyses are completed. Upon DTA completion, access will be granted to a secured, cloud-based dataset monitored by the Information Technology Department.
• IPD Sharing Time Frame: Data will be available May 01, 2021 and will be available for 10 years from that date.
• IPD Sharing Access Criteria: a commitment to using the data only for research purposes and not seek to identify any individual participant; restrictions on redistribution of the data to third parties; a commitment to securing the data using appropriate computer technology; a commitment to destroying or returning the data after analyses are completed; completion of a data-sharing agreement between the researcher requesting data and the University of Missouri
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL