Status:
COMPLETED
Feasibility or Oral Lactoferrin to Prevent Iron Deficiency Anemia in Obese Pregnancy
Lead Sponsor:
University of Illinois at Chicago
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Iron-deficiency
Pregnancy Anemia
Eligibility:
FEMALE
18-45 years
Phase:
NA
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, preve...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 9 2024
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04810546
Start Date
February 1 2022
End Date
October 9 2024
Last Update
November 21 2024
Active Locations (1)
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1
University of Illinois at Chicago
Chicago, Illinois, United States, 60612