Clinical trial NCT04810546: Feasibility or Oral Lactoferrin to Prevent Iron Deficiency Anemia in Obese Pregnancy
Official title: Feasibility or Oral Lactoferrin to Prevent Iron Deficiency Anemia in Obese Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron-deficiency
Pregnancy Anemia
Obesity
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2021-03-23
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Understand feasibility via recruitment and retention rates
timeFrame: Recruitment duration- approximately 3 years
measure: Measure participant adherence
timeFrame: 8 months
measure: Determine preliminary efficacy on maternal inflammation
timeFrame: baseline
measure: Determine preliminary efficacy on maternal inflammation
timeFrame: month 3
measure: Determine preliminary efficacy on maternal inflammation
timeFrame: month 5
measure: Determine preliminary efficacy on maternal inflammation
timeFrame: labor (~month 8)
measure: Determine preliminary efficacy on maternal iron and hematological markers.
timeFrame: baseline
measure: Determine preliminary efficacy on maternal iron and hematological markers.
timeFrame: baseline
measure: Determine preliminary efficacy on maternal iron and hematological markers.
timeFrame: baseline
measure: Determine preliminary efficacy on maternal iron and hematological markers.
timeFrame: baseline
measure: Determine preliminary efficacy on maternal iron and hematological markers.
timeFrame: 1 month
measure: Determine preliminary efficacy on maternal iron and hematological markers.
timeFrame: 1 month
measure: Determine preliminary efficacy on maternal iron and hematological markers.
timeFrame: 1 month
measure: Determine preliminary efficacy on maternal iron and hematological markers.
timeFrame: 1 month
measure: Determine preliminary efficacy on maternal iron and hematological markers.
timeFrame: 2 months
measure: Determine preliminary efficacy on maternal iron and hematological markers.
timeFrame: 2 months
measure: Determine preliminary efficacy on maternal iron and hematological markers.
timeFrame: 2 months
measure: Determine preliminary efficacy on maternal iron and hematological markers.
timeFrame: 2 months
measure: Determine preliminary efficacy on maternal iron and hematological markers.
timeFrame: 3 months
measure: Determine preliminary efficacy on maternal iron and hematological markers.
timeFrame: 3 months
measure: Determine preliminary efficacy on maternal iron and hematological markers.
timeFrame: 3 months
measure: Determine preliminary efficacy on maternal iron and hematological markers.
timeFrame: 3 months
measure: Determine preliminary efficacy on maternal iron and hematological markers.
timeFrame: 4 months
measure: Determine preliminary efficacy on maternal iron and hematological markers.
timeFrame: 4 months
measure: Determine preliminary efficacy on maternal iron and hematological markers.
timeFrame: 4 months
measure: Determine preliminary efficacy on maternal iron and hematological markers.
timeFrame: 4 months
measure: Determine preliminary efficacy on maternal iron and hematological markers.
timeFrame: 5 months
measure: Determine preliminary efficacy on maternal iron and hematological markers.
timeFrame: 5 months
measure: Determine preliminary efficacy on maternal iron and hematological markers.
timeFrame: 5 months
measure: Determine preliminary efficacy on maternal iron and hematological markers.
timeFrame: 5 months
measure: Determine preliminary efficacy on maternal iron and hematological markers.
timeFrame: 6 months
measure: Determine preliminary efficacy on maternal iron and hematological markers.
timeFrame: 6 months
measure: Determine preliminary efficacy on maternal iron and hematological markers.
timeFrame: 6 months
measure: Determine preliminary efficacy on maternal iron and hematological markers.
timeFrame: 6 months
measure: Determine preliminary efficacy on maternal iron and hematological markers.
timeFrame: 7 months
measure: Determine preliminary efficacy on maternal iron and hematological markers.
timeFrame: 7 months
measure: Determine preliminary efficacy on maternal iron and hematological markers.
timeFrame: 7 months
measure: Determine preliminary efficacy on maternal iron and hematological markers.
timeFrame: 7 months
measure: Determine preliminary efficacy on maternal iron and hematological markers.
timeFrame: delivery (~8 months)
measure: Determine preliminary efficacy on maternal iron and hematological markers.
timeFrame: delivery (~8 months)
measure: Determine preliminary efficacy on maternal iron and hematological markers.
timeFrame: delivery (~8 months)
measure: Determine preliminary efficacy on maternal iron and hematological markers.
timeFrame: delivery (~8 months)
measure: Determine preliminary efficacy on maternal hematological markers.
timeFrame: Baseline
measure: Determine preliminary efficacy on maternal hematological markers.
timeFrame: Baseline
measure: Determine preliminary efficacy on maternal hematological markers.
timeFrame: Baseline
measure: Determine preliminary efficacy on maternal hematological markers.
timeFrame: 3 months
measure: Determine preliminary efficacy on maternal hematological markers.
timeFrame: 3 months
measure: Determine preliminary efficacy on maternal hematological markers.
timeFrame: 3 months
measure: Determine preliminary efficacy on maternal hematological markers.
timeFrame: 5 months
measure: Determine preliminary efficacy on maternal hematological markers.
timeFrame: 5 months
measure: Determine preliminary efficacy on maternal hematological markers.
timeFrame: 5 months
measure: Determine preliminary efficacy on maternal hematological markers.
timeFrame: Delivery (~8 months)
measure: Determine preliminary efficacy on maternal hematological markers.
timeFrame: Delivery (~8 months)
measure: Determine preliminary efficacy on maternal hematological markers.
timeFrame: Delivery (~8 months)
measure: Determine preliminary efficacy on neonatal iron and hematological markers.
timeFrame: Delivery (~8 months)
measure: Determine preliminary efficacy on neonatal iron and hematological markers.
timeFrame: Delivery (~8 months)
measure: Determine preliminary efficacy on neonatal iron and hematological markers.
timeFrame: Delivery (~8 months)
measure: Determine preliminary efficacy on neonatal iron and hematological markers.
timeFrame: Delivery (~8 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Mary Dawn Koenig, PhD
role: PRINCIPAL_INVESTIGATOR
References: