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| ID | Type | Description | Link |
|---|---|---|---|
| R34HL155481 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Jarrow Formulas Oral Bovine Lactoferrin Supplement | Dietary Supplement | Lactoferrin (Apolactoferrin) 250mg contains ~17.6 mg/100g of iron |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment Feasibility | % of women approach and eligble who enrolled | 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 | 8 months |
| Participant Retention | % of women retained by study arm through the end of the study (labor and delivery) | 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| % 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 | interval of 5-6 months |
| Cord Ferritin ng/mL |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary Dawn Koenig, PhD | University of Illinois at Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Illinois at Chicago | Chicago | Illinois | 60612 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Jarrow Formulas Oral Bovine Lactoferrin Supplement: Lactoferrin (Apolactoferrin) 250mg contains ~17.6 mg/100g of iron |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Jarrow Formulas Oral Bovine Lactoferrin Supplement: Lactoferrin (Apolactoferrin) 250mg contains ~17.6 mg/100g of iron |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Recruitment Feasibility | % of women approach and eligble who enrolled | Number of women eligible and approached. | Posted | Number | percentage eligible and enrolled | Recruitment duration- approximately 3 years |
|
|
8 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Jarrow Formulas Oral Bovine Lactoferrin Supplement: Lactoferrin (Apolactoferrin) 250mg contains ~17.6 mg/100g of iron |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-serious AE | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mary Dawn Koenig | University of Illinois Chicago | 312-996-7942 | marydh@uic.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 17, 2024 | Jan 28, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D018798 | Anemia, Iron-Deficiency |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D000747 | Anemia, Hypochromic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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measured from cord blood obtained following labor and delivery |
| Following delivery of the neonate |
| Cord Hemoglobin g/dl | Cord CBC. Cord CBC which includes Hb, will at following labor and delivery | 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 | interval of 5-6 months |
| % Change in Maternal Hemoglobin mg/dl | measured from whole blood at baseline and in the third trimester of pregnancy | interval of 5-6 months |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Screening Hemoglobin g/dL12 | Mean | Standard Deviation | grams per deciliter |
|
|
| Primary | Participant Adherence to Lactoferrin - Interventiom Arm | Hand pill counts by the investigational drug service to determine % days compliant while enrolled in the trial | Posted | Mean | Standard Deviation | percentage of days adherent | 8 months |
|
|
|
| Primary | Participant Retention | % of women retained by study arm through the end of the study (labor and delivery) | Posted | Number | percentage of participants retained | 8 months |
|
|
|
| Secondary | % 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 | Posted | Mean | Standard Deviation | percentage of change from baseline | interval of 5-6 months |
|
|
|
| Secondary | Cord Ferritin ng/mL | measured from cord blood obtained following labor and delivery | Posted | Mean | Standard Deviation | ng/mL | Following delivery of the neonate |
|
|
|
| Secondary | Cord Hemoglobin g/dl | Cord CBC. Cord CBC which includes Hb, will at following labor and delivery | Posted | Mean | Standard Deviation | g/dL | Following delivery of the neonate |
|
|
|
| Secondary | % Change in Maternal Ferritin ng/mL | % change in maternal ferritin measured from serum obtained at baseline and the third trimester of pregnancy | Posted | Mean | Standard Deviation | percentage of change from baseline | interval of 5-6 months |
|
|
|
| Secondary | % Change in Maternal Hemoglobin mg/dl | measured from whole blood at baseline and in the third trimester of pregnancy | Posted | Mean | Standard Deviation | percentage of change from baseline | interval of 5-6 months |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 11 |
| 12 |
| EG001 | 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. | 0 | 11 | 0 | 11 | 8 | 11 |
| Obstetrics ER visit non-Gastrointestinal | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
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| D000090463 |
| Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |