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

Last updated: November 18, 2024
Sponsor: University of Illinois at Chicago
Overall Status: Completed

Phase

N/A

Condition

Diabetes Prevention

Obesity

Anemia

Treatment

Jarrow Formulas Oral Bovine Lactoferrin Supplement

Clinical Study ID

NCT04810546
2020-1297
R34HL155481
  • Ages 18-45
  • Female
  • Accepts Healthy Volunteers

Study 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

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 (secondtrimester) for non-Black women and 10.2 - 11.2 g/dL (first trimester)/9.7 -- 10.7g/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 recentpre-conception weight (within 3 months of pregnancy) from EMR if available orself-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 theCenter for Women's Health)

Exclusion

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 withthe interventions, hence these women will also be excluded.

Study Design

Total Participants: 25
Treatment Group(s): 1
Primary Treatment: Jarrow Formulas Oral Bovine Lactoferrin Supplement
Phase:
Study Start date:
February 01, 2022
Estimated Completion Date:
October 09, 2024

Connect with a study center

  • University of Illinois at Chicago

    Chicago, Illinois 60612
    United States

    Site Not Available

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