# Feasibility of oral lactoferrin to prevent iron deficiency anemia in obese pregnancy

> **NIH NIH R34** · UNIVERSITY OF ILLINOIS AT CHICAGO · 2021 · $239,850

## Abstract

ABSTRACT
Maternal iron deficiency anemia (IDA) increases the risk of adverse pregnancy outcomes and can negatively
impact the iron endowment of the neonate that may cause irreversible deleterious effects on neurodevelopment.
To avert IDA in pregnancy, women are universally prescribed a daily oral supplement containing ~27 mg of iron.
However, there is growing concern regarding the efficacy of this one-size-fits-all approach for women with
systemic inflammation, including women with obesity. Obese women experience disruption to the hepcidin-
ferroportin complex deeming iron from diet, including supplemental iron, and body stores less bioavailable. This
indicates an urgent need to develop and test new methods to prevent maternal IDA among women with obesity.
In this planning grant application, we will develop the clinical and research infrastructure to test the preliminary
efficacy of oral bovine lactoferrin (bLf) supplementation for the prevention of maternal IDA among obese women.
Lactoferrin is a natural compound found in secretions from mammals, including milk, and is an important
regulator of body iron balance given its effects on inflammation and the hepcidin-ferroportin complex. Daily oral
bLf has been shown to be superior to oral iron supplementation for treating IDA in pregnant women with
inflammation but has not been studied for its ability to prevent IDA in pregnancy. The specific aims of this clinical
trial planning grant include: 1) Establish the clinical and research infrastructure to recruit, enroll, and randomize
obese women at risk of IDA to an oral bLf intervention in pregnancy. In this aim we will establish, test, refine and
finalize the clinical and research infrastructure and implementation procedures, including a provider referral
system, real-time adherence monitoring, and data infrastructure; and 2) Pilot test a randomized controlled trial
of oral bLf supplementation from early second trimester up through delivery among 40 pregnant women with
obesity at risk of IDA. In this aim we seek to understand recruitment, adherence, and retention rates and
intervention acceptability to determine feasibility and preliminary efficacy on maternal inflammation and maternal
and neonatal iron and hematological-related markers. This study will provide first of its kind data, necessary and
sufficient to inform and develop a large-scale efficacy trial of oral bLf as a safe and scalable natural compound
for the prevention of IDA among obese women. Ultimately if successful, this project is an important first step
toward improving prenatal care for obese women who represent more than a third of reproductive-age women
in the United States.

## Key facts

- **NIH application ID:** 10107101
- **Project number:** 1R34HL155481-01
- **Recipient organization:** UNIVERSITY OF ILLINOIS AT CHICAGO
- **Principal Investigator:** Mary Dawn Koenig
- **Activity code:** R34 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $239,850
- **Award type:** 1
- **Project period:** 2021-02-20 → 2024-01-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10107101

## Citation

> US National Institutes of Health, RePORTER application 10107101, Feasibility of oral lactoferrin to prevent iron deficiency anemia in obese pregnancy (1R34HL155481-01). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10107101. Licensed CC0.

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