University of Illinois at Chicago
Chicago, Illinois, 60612, United States
NCT Number: NCT04810546
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.
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Notify Me18 year–45 year
Female
Interventional
Not applicable
Chicago, Illinois, 60612, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Lactoferrin (Apolactoferrin) 250mg contains ~17.6 mg/100g of iron
Time frame: Recruitment duration- approximately 3 years
% of women approach and eligble who enrolled
Time frame: 8 months
Hand pill counts by the investigational drug service to determine % days compliant while enrolled in the trial
Time frame: 8 months
% of women retained by study arm through the end of the study (labor and delivery)
Time frame: interval of 5-6 months
% change in C-reactive protein from baseline to third trimester measured in serum at baseline and in the third trimester of pregnancy
Time frame: Following delivery of the neonate
measured from cord blood obtained following labor and delivery
Time frame: Following delivery of the neonate
Cord CBC. Cord CBC which includes Hb, will at following labor and delivery
Time frame: interval of 5-6 months
% change in maternal ferritin measured from serum obtained at baseline and the third trimester of pregnancy
Time frame: interval of 5-6 months
measured from whole blood at baseline and in the third trimester of pregnancy
University of Illinois at Chicago
Other
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