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NCT03838536 · ClinicalTrials.gov registry record · NA
Synergistic Activity of Human Milk Nutrients and Infant Cognition
A NA study of Breastfeeding, Exclusive, sponsored by University of North Carolina, Chapel Hill.
- Recruiting
- Registry status
- NA
- Development phase
- 84
- Enrollment target
- 1
- Study location
NCT03838536: Recruiting NA study of Breastfeeding, Exclusive, sponsored by University of North Carolina, Chapel Hill.
NCT03838536 is a NA study of Breastfeeding, Exclusive that is actively recruiting participants, run by University of North Carolina, Chapel Hill. The registered enrollment target is 84 participants, below the 475-participant average among 8 other Breastfeeding, Exclusive trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03838536, a NA study of Breastfeeding, Exclusive, is actively recruiting participants, sponsored by University of North Carolina, Chapel Hill.
- RECRUITING
- Registry status
- NA
- Development phase
- 84 participants
- Enrollment target
- 1
- Study location
Study Summary
Purpose: To establish a whole food, egg, as a viable study material to supplement mothers and infants with nutrients that support optimal brain development. There will be 84 breastfeeding dyads, 3 months postnatal. Mothers will be randomized to a whole egg or egg white (due to lack of an appropriate control food). Initial diet intake will be screened using the NDSR. Participants will come to the lab 3 times across 3 months (age 3 months, 4.5 months, and 6 months). Milk, saliva, and plasma will be collected from the mother, while saliva and plasma (heel stick) are collected from the infant. Diet data will be collected at each visit. The infant will complete a recognition memory test using electrophysiology at 6 months as well as the Bayley Scales of Infant Development at 4.5 months. The mother will complete a temperament questionnaire at 3 months and 6 months.
Primary Outcome
The difference in microvolts between the negative deflection to novel pictures and the negative deflection to familiar pictures at approximately 100-400ms after the pictures come on the screen will be measured in an event-related potentials (ERP) paradigm. The investigators hypothesize that the whole egg group will have better memory for the familiar pictures than the egg white group.
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Whole Egg Powder
- DIETARY_SUPPLEMENT Egg White Powder
Study Locations (1)
North Carolina
- Nutrition Research Institute - Kannapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2019-02-05 |
| Est. Completion | 2026-03 |
| Phase | NA |
What NCT03838536 shows while recruiting
NCT03838536 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, below the 475-participant average among 8 other Breastfeeding, Exclusive trials with a reported enrollment target (82% lower).
The record links to 1 condition, with Breastfeeding, Exclusive appearing as the primary indexed condition, and to 2 interventions - of which Whole Egg Powder is the first listed.
NCT03838536 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT03838536 about?
NCT03838536 is a clinical study titled "Synergistic Activity of Human Milk Nutrients and Infant Cognition". Purpose: To establish a whole food, egg, as a viable study material to supplement mothers and infants with nutrients that support optimal brain development. There will be 84 breastfeeding dyads, 3 months postnatal. Mothers will be randomized to a whole egg or egg white (due to lack of an appropriat...
What is the current status of trial NCT03838536?
This trial is currently recruiting. It is a NA study. The enrollment target is 84 participants. The study started on 2019-02-05. Estimated completion is 2026-03.
What conditions does trial NCT03838536 study?
This clinical trial studies the following conditions: Breastfeeding, Exclusive.
What interventions are being tested in trial NCT03838536?
The interventions under investigation include: Whole Egg Powder (DIETARY_SUPPLEMENT), Egg White Powder (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT03838536?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03838536 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breastfeeding, Exclusive
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03838536's enrollment target sits among peer trials
84 6th of 8 higher than 3 of 8 other Breastfeeding, Exclusive trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breastfeeding, Exclusive trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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