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NCT04810546 · ClinicalTrials.gov registry record · NA
Feasibility or Oral Lactoferrin to Prevent Iron Deficiency Anemia in Obese Pregnancy
A NA study of Obesity and Iron-deficiency, sponsored by University of Illinois at Chicago.
- Completed
- Registry status
- NA
- Development phase
- 23
- Enrollment target
- 1
- Study location
NCT04810546 is a NA study of Obesity and Iron-deficiency that has completed, run by University of Illinois at Chicago. The registered enrollment target is 23 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04810546, a NA study of Obesity and Iron-deficiency, has completed, sponsored by University of Illinois at Chicago.
- COMPLETED
- Registry status
- NA
- Development phase
- 23 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- DIETARY_SUPPLEMENT Jarrow Formulas Oral Bovine Lactoferrin Supplement
Study Locations (1)
Illinois
- University of Illinois at Chicago - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2022-02-01 |
| Est. Completion | 2024-10-09 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04810546
The ClinicalTrials.gov registry entry for NCT04810546 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (97% lower). The listed sponsor is University of Illinois at Chicago, which has 430 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Obesity appearing as the primary indexed condition, and to 1 intervention - of which Jarrow Formulas Oral Bovine Lactoferrin Supplement is the first listed.
NCT04810546 reports 1 study location spanning 1 distinct geographic area - top geographies include Illinois.
Frequently Asked Questions
What is clinical trial NCT04810546 about?
NCT04810546 is a clinical study titled "Feasibility or Oral Lactoferrin to Prevent Iron Deficiency Anemia in Obese Pregnancy". 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 greate...
What is the current status of trial NCT04810546?
This trial is currently completed. It is a NA study. The enrollment target is 23 participants. The study started on 2022-02-01. Estimated completion is 2024-10-09.
What conditions does trial NCT04810546 study?
This clinical trial studies the following conditions: Obesity, Iron-deficiency, Pregnancy Anemia.
What interventions are being tested in trial NCT04810546?
The interventions under investigation include: Jarrow Formulas Oral Bovine Lactoferrin Supplement (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT04810546?
This trial is sponsored by University of Illinois at Chicago, which has 430 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04810546 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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