Iron-deficiencyNCT04810546
Feasibility or Oral Lactoferrin to Prevent Iron Deficiency Anemia in Obese Pregnancy
A study testing Jarrow Formulas Oral Bovine Lactoferrin Supplement in people with Iron-deficiency and Pregnancy Anemia, run by University of Illinois Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron-deficiency, Pregnancy Anemia, Obesity
- What is being tested?
- Jarrow Formulas Oral Bovine Lactoferrin Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2022to 9 Oct 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 19Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Chicago
Chicago, Illinois, 60612
About this study
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.
- Conditions
- Iron-deficiency, Pregnancy Anemia, Obesity
- Being tested
- Jarrow Formulas Oral Bovine Lactoferrin Supplement
- Medical subject headings
- Anemia, Iron-Deficiency, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jarrow Formulas Oral Bovine Lactoferrin SupplementDietary supplement
Lactoferrin (Apolactoferrin) 250mg contains ~17.6 mg/100g of iron
| Study group | Role | What they receive |
|---|---|---|
| Jarrow Formulas Oral Bovine Lactoferrin Supplement | Experimental | 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. Receives: Dietary Supplement: Jarrow Formulas Oral Bovine Lactoferrin Supplement |
| Usual care | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Feasibility
% of women approach and eligble who enrolled
Measured: 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
Measured: 8 months
Participant Retention
% of women retained by study arm through the end of the study (labor and delivery)
Measured: 8 months
Secondary outcomes (5)
% 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
Measured: interval of 5-6 months
Cord Ferritin ng/mL
measured from cord blood obtained following labor and delivery
Measured: Following delivery of the neonate
Cord Hemoglobin g/dl
Cord CBC. Cord CBC which includes Hb, will at following labor and delivery
Measured: 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
Measured: interval of 5-6 months
% Change in Maternal Hemoglobin mg/dl
measured from whole blood at baseline and in the third trimester of pregnancy
Measured: interval of 5-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start1 Feb 2022
- Primary completion9 Oct 2024
- Study completion9 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Iron-deficiencyStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Mary Dawn Koenig, University of Illinois Chicago
- Investigators
- Mary Dawn Koenig, PhD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04810546
- Sponsor's protocol ID
- 2020-1297
- Other IDs
- R34HL155481
- Status last verified
- Nov 2024
- First submitted
- 22 Feb 2021
- Last updated
- 17 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility or Oral Lactoferrin to Prevent Iron Deficiency Anemia in Obese Pregnancy
- ClinicalTrials.gov ID
- NCT04810546
- Acronym / sponsor ID
- 2020-1297
- Conditions
- Iron-deficiency, Pregnancy Anemia, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 9 Oct 2024 (actual)
- Study completion
- 9 Oct 2024 (actual)
- First posted
- 23 Mar 2021 (actual)
- Results
- Posted 17 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Jarrow Formulas Oral Bovine Lactoferrin Supplement | Experimental | Dietary Supplement: Jarrow Formulas Oral Bovine Lactoferrin SupplementOnce 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. |
| Usual care | No intervention | –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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Jarrow Formulas Oral Bovine Lactoferrin SupplementLactoferrin (Apolactoferrin) 250mg contains ~17.6 mg/100g of iron | Dietary supplement | Jarrow Formulas Oral Bovine Lactoferrin Supplement |
Primary outcome
Recruitment Feasibility
Time frame: Recruitment duration- approximately 3 years
% of women approach and eligble who enrolled
Participant Adherence to Lactoferrin - Interventiom Arm
Time frame: 8 months
Hand pill counts by the investigational drug service to determine % days compliant while enrolled in the trial
Participant Retention
Time frame: 8 months
% of women retained by study arm through the end of the study (labor and delivery)
5 secondary outcomes
% Change in C-reactive Protein mg/L Between Baseline and Third Trimester
Time frame: interval of 5-6 months
Cord Ferritin ng/mL
Time frame: Following delivery of the neonate
Cord Hemoglobin g/dl
Time frame: Following delivery of the neonate
% Change in Maternal Ferritin ng/mL
Time frame: interval of 5-6 months
% Change in Maternal Hemoglobin mg/dl
Time frame: interval of 5-6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary Dawn Koenig, PhD principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Jarrow Formulas Oral Bovine Lactoferrin Supplement in people with Iron-deficiency and Pregnancy Anemia, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Feasibility (time frame: Recruitment duration- approximately 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.