Feasibility or Oral Lactoferrin to Prevent Iron Deficiency Anemia in Obese Pregnancy

NCT ID: NCT04810546

Last Updated: 2024-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2024-10-09

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.

Conditions

Iron-deficiency; Pregnancy Anemia; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Jarrow Formulas Oral Bovine Lactoferrin Supplement

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.

Group Type: EXPERIMENTAL

Jarrow Formulas Oral Bovine Lactoferrin Supplement

Intervention Type: DIETARY_SUPPLEMENT

Lactoferrin (Apolactoferrin) 250mg contains \~17.6 mg/100g of iron

Usual care

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Jarrow Formulas Oral Bovine Lactoferrin Supplement

Lactoferrin (Apolactoferrin) 250mg contains \~17.6 mg/100g of iron

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Illinois at Chicago

OTHER

Sponsor Role: lead

Responsible Party

Mary Dawn Koenig

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mary Dawn Koenig, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Chicago

Locations

University of Illinois at Chicago

Chicago, Illinois, United States

Countries

United States

Other Identifiers

R34HL155481

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2020-1297

Identifier Type: -

Identifier Source: org_study_id