Maternal iron deficiency anemia is associated with maternal and infant mortality, spontaneous preterm birth, maternal postpartum hemorrhage, and neurocognitive defects in the neonate. Therefore, preventing maternal iron deficiency anemia in at-risk women is critical. Obese pregnant women have greater systemic inflammation and circulating hepcidin levels compared to nonobese pregnant women. This phenotype implies obese pregnant women have decreased iron bioavailability and may be less responsive to oral iron supplementation because hepcidin is a negative regulator of dietary iron absorption, suggesting alternative interventions are needed to optimize their iron status in pregnancy. There is increasing evidence that consuming the oral bovine lactoferrin (bLf) can enhance dietary iron absorption by promoting an anti-inflammatory immune response and hepcidin suppression, indicating this intervention may be beneficial to pregnant obese women at risk for iron deficiency anemia. The primary goal of this study is to test the feasibility and acceptability of this low-cost, safe, innovative approach to optimizing maternal iron status in obese women at risk of iron deficiency anemia (Hb 11.0 - 12.0 g/dL (first trimester)/10.5 - 11.5 g/dL (second trimester) for non-Black women and 10.2 - 11.2 g/dL (first trimester)/9.7 -- 10.7 g/dL (second trimester) for Black women) from 15-20 weeks of gestation (WG) until the time of labor. The investigators will explore effects on maternal and neonatal iron status and Hb and changes to maternal systemic inflammation and circulating hepcidin. This study is an essential first step toward evaluating if daily oral bLf is an efficacious, safe, inexpensive, and scalable clinical strategy for the prevention of maternal iron deficiency anemia and its related complications in at-risk women.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
23
Lactoferrin (Apolactoferrin) 250mg contains \~17.6 mg/100g of iron
University of Illinois at Chicago
Chicago, Illinois, United States
Recruitment Feasibility
% of women approach and eligble who enrolled
Time frame: Recruitment duration- approximately 3 years
Participant Adherence to Lactoferrin - Interventiom Arm
Hand pill counts by the investigational drug service to determine % days compliant while enrolled in the trial
Time frame: 8 months
Participant Retention
% of women retained by study arm through the end of the study (labor and delivery)
Time frame: 8 months
% Change in C-reactive Protein mg/L Between Baseline and Third Trimester
% change in C-reactive protein from baseline to third trimester measured in serum at baseline and in the third trimester of pregnancy
Time frame: interval of 5-6 months
Cord Ferritin ng/mL
measured from cord blood obtained following labor and delivery
Time frame: Following delivery of the neonate
Cord Hemoglobin g/dl
Cord CBC. Cord CBC which includes Hb, will at following labor and delivery
Time frame: Following delivery of the neonate
% Change in Maternal Ferritin ng/mL
% change in maternal ferritin measured from serum obtained at baseline and the third trimester of pregnancy
Time frame: interval of 5-6 months
% Change in Maternal Hemoglobin mg/dl
measured from whole blood at baseline and in the third trimester of pregnancy
Time frame: interval of 5-6 months
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