Feasibility or Oral Lactoferrin to Prevent Iron Deficiency Anemia in Obese Pregnancy (NCT04810546) | Clinical Trial Compass
CompletedNot Applicable
Feasibility or Oral Lactoferrin to Prevent Iron Deficiency Anemia in Obese Pregnancy
United States23 participantsStarted 2022-02-01
Plain-language 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.
Who can participate
Age range
18 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 \[based on measured height in EMR and recent pre-conception weight (within 3 months of pregnancy) from EMR if available or self-reported\]; \< 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)
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)
* regu…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Recruitment Feasibility
Timeframe: Recruitment duration- approximately 3 years
2
Participant Adherence to Lactoferrin - Interventiom Arm