Maternal iron deficiency anemia (IDA) increases the risk of adverse pregnancy outcomes and can negatively impact the iron endowment of the neonate that may cause irreversible deleterious effects on neurodevelopment. To avert IDA in pregnancy, women are universally prescribed a daily oral supplement containing ~27 mg of iron. However, there is growing concern regarding the efficacy of this one-size-fits-all approach for women with systemic inflammation, including women with obesity. Obese women experience disruption to the hepcidin- ferroportin complex deeming iron from diet, including supplemental iron, and body stores less bioavailable. This indicates an urgent need to develop and test new methods to prevent maternal IDA among women with obesity. In this planning grant application, we will develop the clinical and research infrastructure to test the preliminary efficacy of oral bovine lactoferrin (bLf) supplementation for the prevention of maternal IDA among obese women. Lactoferrin is a natural compound found in secretions from mammals, including milk, and is an important regulator of body iron balance given its effects on inflammation and the hepcidin-ferroportin complex. Daily oral bLf has been shown to be superior to oral iron supplementation for treating IDA in pregnant women with inflammation but has not been studied for its ability to prevent IDA in pregnancy.
The specific aims of this clinical trial planning grant include: 1) Establish the clinical and research infrastructure to recruit, enroll, and randomize obese women at risk of IDA to an oral bLf intervention in pregnancy. In this aim we will establish, test, refine and finalize the clinical and research infrastructure and implementation procedures, including a provider referral system, real-time adherence monitoring, and data infrastructure; and 2) Pilot test a randomized controlled trial of oral bLf supplementation from early second trimester up through delivery among 40 pregnant women with obesity at risk of IDA. In this aim we seek to understand recruitment, adherence, and retention rates and intervention acceptability to determine feasibility and preliminary efficacy on maternal inflammation and maternal and neonatal iron and hematological-related markers. This study will provide first of its kind data, necessary and sufficient to inform and develop a large-scale efficacy trial of oral bLf as a safe and scalable natural compound for the prevention of IDA among obese women. Ultimately if successful, this project is an important first step toward improving prenatal care for obese women who represent more than a third of reproductive-age women in the United States.
Pregnant women in the U.S. are prescribed a daily prenatal supplement containing iron to prevent iron deficiency anemia (IDA), a condition associated with adverse maternal and neonatal health. However, this one-size-fits-all approach to preventing IDA may not be appropriate for women with inflammation, including obese women. We propose to test oral lactoferrin along with a prenatal supplement devoid of iron in obese pregnant women to assess whether it is feasible, acceptable, and potentially more effective at preventing IDA than a traditional daily prenatal supplement containing iron.