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

A Randomized Trial of Intermittent Oral Iron Supplementation vs. Daily Oral Iron Supplementation for the Treatment of Anemia in Pregnancy

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.

Study Overview

• Status: Terminated
• Conditions: Pregnancy Related; Iron Deficiency Anemia of Pregnancy
• Intervention / Treatment: Drug: Ferrous sulfate

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Texas
    • Galveston, Texas, United States, 77555
      • University of Texas Medical Branch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Daily iron supplementation; Oral ferrous sulfate, 325 mg, take once daily	Drug: Ferrous sulfate; Iron supplementation
Experimental: Alternate day iron supplementation; Oral ferrous sulfated, 650mg, taken once daily every other day	Drug: Ferrous sulfate; Iron supplementation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in Hemoglobin Levels From Enrollment to End of Study	Hemoglobin levels will be assessed by blood draw upon enrollment and again in the third trimester of pregnancy	Baseline and again 8-9 months later (third trimester of pregnancy)
Change in Hematocrit in the Third Trimester After Treatment	Hematocrit levels will be assessed by blood draw upon enrollment and again in the third trimester of pregnancy	Baseline and again 8-9 months later (third trimester of pregnancy)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastrointestinal Side Effects After 2-4 Weeks of Treatment	Gastrointestinal side effects with treatment will be assessed by telephone survey using a validated questionnaire.	2-4 weeks after enrollment
Complete Blood Count in the Third Trimester	Complete blood count indices will be assessed by blood draw upon enrollment and approximately monthly until delivery	8-9 months after enrollment (third trimester of pregnancy)
Serum Ferritin at Time of Enrollment	Serum ferritin will assessed by blood draw at time of enrollment.	Baseline only at time of enrollment
Total Iron Binding Capacity at Time of Enrollment	Total iron binding capacity will assessed by blood draw at time of enrollment.	Baseline only at time of enrollment
Transferrin at Time of Enrollment	Transferrin levels will assessed by blood draw at time of enrollment.	Baseline only at time of enrollment
Number of Participants Who Receive Intravenous (IV) Iron Supplementation	By chart review, we will determine if the subject received parental (IV) iron supplementation as part of the treatment for iron deficiency anemia	At completion of study, on average after 9 months
Number of Participants Who Receive a Blood Transfusion	By chart review, we will determine if the subject received a blood transfusion as part of the treatment for iron deficiency anemia	At completion of study, on average after 9 months
Postpartum Hemoglobin	Hemoglobin levels after delivery will be recorded (if obtained as part of regular postpartum care)	At completion of study, on average after 9 months
Postpartum Hematocrit	Hematocrit levels after delivery will be recorded (if obtained as part of regular postpartum care)	At completion of study, on average after 9 months
Neonatal Weight at Delivery	The weight of the baby (in grams) will be determined by chart review at the end of enrollment	At completion of study, on average after 9 months
Level of Neonatal Bilirubin at Birth	Neonatal hyperbilirubinemia will be reviewed and recorded by chart review	At completion of study, on average after 9 months
Neonatal Apgar Scores	Neonatal Apgar scores will be reviewed and recorded by chart review. The Apgar score is a method used to describe a newborn's status at birth and response to resuscitation. The Apgar score comprises five components: 1) color, 2) heart rate, 3) reflexes, 4) muscle tone, and 5) respiration, each of which is given a score of 0, 1, or 2. The range of scores is 0 to 10. Higher scores indicate reassuring newborn status.	At completion of study, on average after 9 months
Number of Newborns Who Are Admitted to the Neonatal Intensive Care Unit (NICU).	The need for Neonatal Intensive Care Unit (NICU) Admission, will be assessed	At completion of study, on average after 9 months
Weight Class at Time of Enrollment	At time of enrollment the weight of the subject will be assessed and assigned a weight class using the World Health Organization weight classification	Baseline only at time of enrollment

Collaborators and Investigators

• Sponsor: The University of Texas Medical Branch, Galveston
• Investigators: Principal Investigator: Melody Safarzadeh, MD, MS, UTMB

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2020
• Primary Completion (Actual): January 12, 2024
• Study Completion (Actual): January 12, 2024

Study Registration Dates

• First Submitted: September 30, 2020
• First Submitted That Met QC Criteria: October 14, 2020
• First Posted (Actual): October 20, 2020

Study Record Updates

• Last Update Posted (Actual): June 24, 2024
• Last Update Submitted That Met QC Criteria: June 18, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Pregnancy; Anemia; Iron supplementation; Iron deficiency
• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Anemia, Hypochromic; Iron Metabolism Disorders; Anemia, Iron-Deficiency; Anemia; Iron Deficiencies
• Other Study ID Numbers: 20-0068

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No