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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up recruitment duration- approximately 3 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am between 18 and 45 years old.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determine preliminary efficacy on maternal hematological markers.
Determine preliminary efficacy on maternal inflammation
Determine preliminary efficacy on maternal iron and hematological markers.
+3 moreSide effects data
From 2018 Phase 2 trial • 55 Patients • NCT018305952%
Hospitalized for syncope episode
2%
Cough, congestion, sinus pressure, fatigue
2%
Bone spur on spine
2%
surgery on rotator cuff
2%
torn rotator cuff
2%
Depression
2%
Elevated CK
2%
Bone
2%
Fatigue, cough and sore throat
2%
tinnitus
2%
right leg pain
2%
Upper Respiratory infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Recombinant Lactoferrin
Placebo
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.
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Who is running the clinical trial?
University of Illinois at ChicagoLead Sponsor
607 Previous Clinical Trials
1,559,315 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,835 Previous Clinical Trials
47,310,602 Total Patients Enrolled
Mary KoenigPrincipal InvestigatorUniversity of Illinois at Chicago
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic to milk or wheat.Your water has broken too early or you have an infection in the sac around the baby.I have been diagnosed with diabetes.My BMI was 30 or higher before I got pregnant, based on my last measurements.You have low hemoglobin levels that put you at risk for iron deficiency anemia, based on recent blood test results.You are currently using tobacco, alcohol, or illegal drugs (including marijuana).You have a smartphone.I have a condition that affects my body's ability to absorb nutrients.I am between 18 and 45 years old.If you are experiencing unstable housing, high PHQ-9 score in the first trimester, or have recently experienced a traumatic event, you may not be able to follow the study's treatments, so you will not be able to participate.I have an autoimmune disorder like rheumatoid arthritis.You currently have an eating disorder.I have inflammatory bowel disease.Gave birth or were pregnant in the last 12 months.I need high doses of iron supplements for my anemia.You have had a baby born too early without any medical reason.I have had weight loss surgery in the past.You are pregnant with one baby, conceived without any medical assistance.You are excluded if you follow a vegan diet because of the supplements used in the study.I have a blood disorder like hemochromatosis or β-thalassemia.I am experiencing severe nausea and vomiting.I have recently received a blood transfusion.I regularly take medication that could affect how my body absorbs nutrients.I am currently fighting an infection.
Research Study Groups:
This trial has the following groups:- Group 1: Jarrow Formulas Oral Bovine Lactoferrin Supplement
- Group 2: Usual care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the criteria for this research include those aged above 35?
"As per the specified terms of participation, minimal age for inclusion in this study is 18 years old and maximal age for enrollment 45."
Answered by AI
Is there currently an opportunity for people to enroll in this investigation?
"The clinicaltrials.gov data confirms that the deadline for recruitment has passed on this trial, which was posted February 1st 2022 and last updated August 15th 2022. 1207 other medical studies are actively searching for patients to participate in their trials as of now."
Answered by AI
Can I take part in this medical experiment?
"Qualified individuals must have obesity and be between 18-45 years of age to join this medical trial. 40 patients are currently being recruited for the study."
Answered by AI
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