NCT04810546Completed
Feasibility or Oral Lactoferrin to Prevent Iron Deficiency Anemia in Obese Pregnancy
Source: ClinicalTrials.gov · Last updated 17 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 23 (actual)
- First submitted
- 22 Feb 2021
- Start date
- Feb 2022
- Primary completion date
- Oct 2024
- Lead sponsor
- University of Illinois Chicago
- Diseases
- Obesity
- NCT number
- NCT04810546
What you commit to
- Study type: Interventional
- Participants enrolled: 23
- From Feb 2022 to the primary completion date, Oct 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- birth, or other pregnancy in the previous 12 months
- previously diagnosed type 1 or type 2 diabetes
- previous spontaneous preterm birth
- current tobacco, alcohol or illicit drug use (including marijuana)
- regular use of medications that may interfere with nutrient absorption
Other illness
- allergy to milk proteins or wheat
- autoimmune disorder (e.g., rheumatoid arthritis)
- inflammatory bowel disease
- current bacterial or viral infection
- history of bariatric surgery
- malabsorptive disease
- current eating disorder
- hematologic disorder or trait carrier (e.g., hemochromatosis, β-thalassemia)
Other
- IDA requiring high dose supplemental iron
- vegan (due to content of the supplements)
- recent blood transfusion
- premature rupture of membranes or chorioamnionitis
- current hyperemesis
- 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.
Who the study is looking for
- 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)
Age in the registry: 18 years to 45 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Illinois at Chicago Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.