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Dietary Supplement

Oral Lactoferrin for Pregnancy Anemia

N/A

Waitlist Available

Led By Mary Koenig

Research Sponsored by University of Illinois at Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged 18 - 45 years old

Be between 18 and 65 years old

Must not have

Previously diagnosed type 1 or type 2 diabetes

Autoimmune disorder (e.g., rheumatoid arthritis)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up recruitment duration- approximately 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the feasibility of using oral bovine lactoferrin to prevent maternal iron deficiency anemia in obese pregnant women.

Who is the study for?

This trial is for obese pregnant women aged 18-45 with a pre-conception BMI ≥30, at risk of iron deficiency anemia (IDA), and who own a smartphone. They must be fluent in English, not have given birth or been pregnant in the last year, and be less than 20 weeks into their pregnancy. Exclusions include various health conditions like allergies to milk proteins or wheat, autoimmune disorders, previous high-risk pregnancies, substance abuse issues, unstable housing situations or recent trauma.

What is being tested?

The study tests if taking Jarrow Formulas Oral Bovine Lactoferrin Supplement can prevent iron deficiency anemia in obese pregnant women by enhancing dietary iron absorption. It aims to see if this low-cost intervention from weeks 15-20 of gestation until labor is feasible and acceptable while monitoring its effects on maternal and neonatal iron levels as well as inflammation markers.

What are the potential side effects?

Potential side effects are not explicitly listed but may include reactions related to milk protein intolerance due to the nature of bovine lactoferrin supplements. Participants will likely be monitored for any adverse reactions typical of dietary supplements.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 45 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with diabetes.

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I have an autoimmune disorder like rheumatoid arthritis.

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I have a condition that affects my body's ability to absorb nutrients.

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I have inflammatory bowel disease.

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I need high doses of iron supplements for my anemia.

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I have had weight loss surgery in the past.

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I have a blood disorder like hemochromatosis or β-thalassemia.

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I am experiencing severe nausea and vomiting.

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I have recently received a blood transfusion.

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I am currently fighting an infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ recruitment duration- approximately 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~recruitment duration- approximately 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and recruitment duration- approximately 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Determine preliminary efficacy on maternal hematological markers.

Determine preliminary efficacy on maternal inflammation

Determine preliminary efficacy on maternal iron and hematological markers.

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Jarrow Formulas Oral Bovine Lactoferrin SupplementExperimental Treatment1 Intervention

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 II: Usual careActive Control1 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.

0 / 11Eligibility criteria met