Feasibility or Oral Lactoferrin to Prevent Iron Deficiency Anemia in Obese Pregnancy

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Iron-deficiency; Pregnancy Anemia
• Intervention / Treatment: Dietary supplement: Jarrow Formulas Oral Bovine Lactoferrin Supplement

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Illinois at Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 41 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Dietary supplement: Jarrow Formulas Oral Bovine Lactoferrin Supplement; Lactoferrin (Apolactoferrin) 250mg contains ~17.6 mg/100g of iron
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment Feasibility	% of women approach and eligble who enrolled	Recruitment duration- approximately 3 years
Participant Adherence to Lactoferrin - Interventiom Arm	Hand pill counts by the investigational drug service to determine % days compliant while enrolled in the trial	8 months
Participant Retention	% of women retained by study arm through the end of the study (labor and delivery)	8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
% Change in C-reactive Protein mg/L Between Baseline and Third Trimester	% change in C-reactive protein from baseline to third trimester measured in serum at baseline and in the third trimester of pregnancy	interval of 5-6 months
Cord Ferritin ng/mL	measured from cord blood obtained following labor and delivery	Following delivery of the neonate
Cord Hemoglobin g/dl	Cord CBC. Cord CBC which includes Hb, will at following labor and delivery	Following delivery of the neonate
% Change in Maternal Ferritin ng/mL	% change in maternal ferritin measured from serum obtained at baseline and the third trimester of pregnancy	interval of 5-6 months
% Change in Maternal Hemoglobin mg/dl	measured from whole blood at baseline and in the third trimester of pregnancy	interval of 5-6 months

Collaborators and Investigators

• Sponsor: University of Illinois at Chicago
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Mary Dawn Koenig, PhD, University of Illinois at Chicago

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Actual): October 9, 2024
• Study Completion (Actual): October 9, 2024

Study Registration Dates

• First Submitted: February 22, 2021
• First Submitted That Met QC Criteria: March 18, 2021
• First Posted (Actual): March 23, 2021

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: January 28, 2026
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Hematologic Diseases; Overweight; Anemia; Iron Metabolism Disorders; Anemia, Hypochromic; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Hemic and Lymphatic Diseases; Iron Deficiencies; Obesity; Anemia, Iron-Deficiency; Anti-Infective Agents; Lactoferrin
• Other Study ID Numbers: 2020-1297; R34HL155481 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No