Feasibility or Oral Lactoferrin to Prevent Iron Deficiency Anemia in Obese Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Recruitment Feasibility
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •naturally conceived, single pregnancy
- •at risk of IDA [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]42 based on new OB complete blood count (CBC) results obtained from the EMR
- •18 - 45 years old
- •pre-conception BMI ≥ 30.0 kg/m2 [based on measured height in EMR and recent pre-conception weight (within 3 months of pregnancy) from EMR if available or self-reported]; < 20 WG
- •fluency in English to provide consent and complete study procedures;
- •ability to provide consent
- •ownership of a smartphone (currently more than 90% of our patient population at the Center for Women's Health)
排除标准
- •birth, or other pregnancy in the previous 12 months
- •IDA requiring high dose supplemental iron
- •allergy to milk proteins or wheat
- •vegan (due to content of the supplements)
- •recent blood transfusion
- •previously diagnosed type 1 or type 2 diabetes
- •autoimmune disorder (e.g., rheumatoid arthritis)
- •inflammatory bowel disease
- •premature rupture of membranes or chorioamnionitis
- •previous spontaneous preterm birth
- •current bacterial or viral infection
- •history of bariatric surgery
- •malabsorptive disease
- •current hyperemesis
- •current eating disorder
- •hematologic disorder or trait carrier (e.g., hemochromatosis, β-thalassemia)
- •current tobacco, alcohol or illicit drug use (including marijuana)
- •regular use of medications that may interfere with nutrient absorption
- •unstable housing, first trimester PHQ-9 score > 10, and/or a recent traumatic event (e.g., death of a significant other or parent) may make it difficult to comply with the interventions, hence these women will also be excluded.
研究组 & 干预措施
Jarrow Formulas Oral Bovine Lactoferrin Supplement
Once daily Oral Lf (250mg). Women assigned to this group will be instructed to consume an oral Lf capsule one hour prior to their afternoon meal and two prenatal vitamin/mineral supplement gummies without iron with omega-3 fatty acids before bed from early second trimester (15 - 20 WG) up through delivery. Women are advised to consume the Lf prior to meals, given our team member Valenti's unpublished work shows its superior efficacy for improving iron and hematological parameters among pregnant women with hereditary thrombophilia versus when consumed with meals. The prenatal vitamin/mineral gummies will be a commercially available product (One-a-Day Women's Prenatal Gummies with omega-3 fatty acids, Bayer Healthcare, Whippany, NJ). Women in both groups will be advised to consume an iron-rich diet and provided a handout detailing foods rich in heme and non-heme iron.
干预措施: Jarrow Formulas Oral Bovine Lactoferrin Supplement (Dietary Supplement)
Usual care
Women assigned to this group will be instructed to consume a commercially available prenatal vitamin/mineral supplement with iron and omega-3 fatty acids (Prenatal 1, Bayer Healthcare, Whippany, NJ) before bed from early second trimester (15-20 WG) through delivery. To minimize variability in prenatal vitamin/supplement use across the participants, we have opted to standardize the prenatal vitamin/mineral supplement by providing women in the usual care arm a supplement that is nutritionally like what is prescribed by the Center for Women's Health providers. Women will be advised to consume an iron-rich diet and provided a handout describing foods rich in heme and non-heme iron.
结局指标
主要结局
Recruitment Feasibility
时间窗: Recruitment duration- approximately 3 years
% of women approach and eligble who enrolled
Participant Adherence to Lactoferrin - Interventiom Arm
时间窗: 8 months
Hand pill counts by the investigational drug service to determine % days compliant while enrolled in the trial
Participant Retention
时间窗: 8 months
% of women retained by study arm through the end of the study (labor and delivery)
次要结局
- % Change in Maternal Hemoglobin mg/dl(interval of 5-6 months)
- % Change in C-reactive Protein mg/L Between Baseline and Third Trimester(interval of 5-6 months)
- Cord Ferritin ng/mL(Following delivery of the neonate)
- Cord Hemoglobin g/dl(Following delivery of the neonate)
- % Change in Maternal Ferritin ng/mL(interval of 5-6 months)
研究者
Mary Dawn Koenig
Associate Professor
University of Illinois at Chicago