N/A
N=23
Feasibility or Oral Lactoferrin to Prevent Iron Deficiency Anemia in Obese Pregnancy
Iron-deficiency · Pregnancy Anemia · Obesity
Bottom Line
View on ClinicalTrials.gov: NCT04810546 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Feb 2026
Primary outcome: Primary: Recruitment Feasibility — 10 percentage eligible and enrolled
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Jarrow Formulas Oral Bovine Lactoferrin Supplement (Dietary_supplement)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Illinois at Chicago
- Primary completion
- Oct 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Recruitment Feasibility |
10 | — |
| PRIMARY Participant Adherence to Lactoferrin - Interventiom Arm |
82.1 | — |
| PRIMARY Participant Retention |
58; 63 | — |
| SECONDARY % Change in C-reactive Protein mg/L Between Baseline and Third Trimester |
-10.4; 26.6 | — |
| SECONDARY Cord Ferritin ng/mL |
177.67; 133.40 | — |
| SECONDARY Cord Hemoglobin g/dl |
14.93; 14.05 | — |
| SECONDARY % Change in Maternal Ferritin ng/mL |
-17.4; -75.0 | — |
| SECONDARY % Change in Maternal Hemoglobin mg/dl |
8.0; 6.1 | — |
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]; 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.
Data sourced from ClinicalTrials.gov (NCT04810546). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.