Iron-deficiency, Obesity, Pregnancy Anemia
Conditions
Brief 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.
Interventions
DIETARY_SUPPLEMENTJarrow Formulas Oral Bovine Lactoferrin Supplement
Lactoferrin (Apolactoferrin) 250mg contains \~17.6 mg/100g of iron
Sponsors
University of Illinois at Chicago
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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) * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment Feasibility | Recruitment duration- approximately 3 years | % of women approach and eligble who enrolled |
| Participant Adherence to Lactoferrin - Interventiom Arm | 8 months | Hand pill counts by the investigational drug service to determine % days compliant while enrolled in the trial |
| Participant Retention | 8 months | % of women retained by study arm through the end of the study (labor and delivery) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| % Change in C-reactive Protein mg/L Between Baseline and Third Trimester | interval of 5-6 months | % change in C-reactive protein from baseline to third trimester measured in serum at baseline and in the third trimester of pregnancy |
| Cord Ferritin ng/mL | Following delivery of the neonate | measured from cord blood obtained following labor and delivery |
| Cord Hemoglobin g/dl | Following delivery of the neonate | Cord CBC. Cord CBC which includes Hb, will at following labor and delivery |
| % Change in Maternal Ferritin ng/mL | interval of 5-6 months | % change in maternal ferritin measured from serum obtained at baseline and the third trimester of pregnancy |
| % Change in Maternal Hemoglobin mg/dl | interval of 5-6 months | measured from whole blood at baseline and in the third trimester of pregnancy |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMary Dawn Koenig, PhD
University of Illinois at Chicago
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 27.1 years STANDARD_DEVIATION 5.12 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 6 Participants |
| Region of Enrollment United States | 11 Participants |
| Screening Hemoglobin g/dL12 | 12.19 grams per deciliter STANDARD_DEVIATION 0.51 |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 11 |
| other Total, other adverse events | 11 / 12 | 8 / 11 |
| serious Total, serious adverse events | 0 / 12 | 0 / 11 |
Outcome results
None listed