Feasibility of oral lactoferrin to prevent iron deficiency anemia in obese pregnancy

口服乳铁蛋白预防肥胖妊娠缺铁性贫血的可行性

• 批准号: 10356064
• 负责人: Mary Dawn Koenig
• 金额: $ 23.99万
• 依托单位: UNIVERSITY OF ILLINOIS AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-02-20 至 2024-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10356064
• 关键词: Adherence; Affect; Age; Anemia due to Chronic Disorder; Applications Grants; Attenuated; Biological Availability; Biological Markers; Blood Circulation; Body mass index; Cattle; Chronic; Clinical Trials; Complex; Data; Diet; Dietary Iron; Endowment; Enrollment; Equilibrium; Erythropoiesis; Ferrous Sulfate; Fetus; Future; Genetic; Glycoproteins; Grant; Hematological Disease; Hematology; Hepatocyte; High Prevalence; Homeostasis; Hormones; Inflammation; Inflammatory; Intake; Intervention; Intervention Trial; Iron; Iron deficiency anemia; Lactoferrin; Liver; Mammals; Maternal Health; Mediating; Methods; Milk; Monitor; National Heart, Lung, and Blood Institute; Neonatal; Non obese; Obesity; Oral; Oral Administration; Patients; Persons; Pregnancy; Pregnant Women; Prenatal care; Prevention; Procedures; Production; Provider; Randomized; Randomized Controlled Trials; Regulation; Research Infrastructure; Risk; Risk Factors; Role; Second Pregnancy Trimester; Small Intestines; Sodium Chloride; Supplementation; System; Testing; Time; United States; Woman; absorption; adherence rate; adverse pregnancy outcome; clinical infrastructure; data infrastructure; design; efficacy trial; experience; feasibility trial; fetal; hepcidin; improved; in utero; iron deficiency; iron supplement; iron supplementation; macrophage; member; metal transporting protein 1; neonatal health; neonate; neurodevelopment; novel; obesity in pregnancy; oral supplementation; overexpression; pilot test; pregnant; prenatal; prepregnancy obesity; prevent; prophylactic; prospective; randomized trial; recruit; reproductive; retention rate; standard of care; systemic inflammatory response; treatment as usual

ABSTRACT 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.

摘要