Fatty Acid Levels and Memory in Breastfed Children | NCT01942434

Studies
Fatty Acid Levels and Memory in Breastfed Children

NCT01942434

Sponsor

University of North Carolina, Chapel Hill

Status

Completed

Last Update Posted

Dec 16, 2020Actual

Enrollment

202Actual

Phase

Not provided

Conditions

Cognitive Development

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010Actual

Primary Completion Date

Nov 2011Actual

Completion Date

Aug 2016Actual

First Submitted Date

Sep 6, 2013

First Submission Date that Met QC Criteria

Sep 10, 2013

First Posted Date

Sep 16, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 11, 2020

Last Update Posted Date

Dec 16, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Carol Cheatham, PhD, Assistant Professor of Psychology, University of North Carolina, Chapel HillPrincipal Investigator

Lead Sponsor

University of North Carolina, Chapel HillOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Purpose: To explore the relation between breastmilk nutrients and the cognitive abilities of breastfed infants.

Phase 1: Near 3 months of age child and mother saliva samples for DNA obtained with breast milk sample.

Phase 2: At 6 months of age child participates in electrophysiology session to test recognition memory.

Phase 3: At 26 or 38 months of age, children will complete behavioral, dietary, and physical assessments.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

202Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Relation between recognition memory and maternal FADS genotype	At 6 months of age, during the second session (Phase 2)	6 months

Secondary Outcomes

Measure	Description	Time Frame
Nutrient content of breastmilk as it relates to FADS genotype	Sample provided in session 1 when the infant was 3-4 months old (Phase 1)	3 to 4 months
Nutrient content of breastmilk as it relates to recognition memory

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

typically-developing
exclusively breastfed
unremarkable delivery

Exclusion Criteria:

non-English speaking
history of seizure activity

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Months

Maximum Age

4 Months

Standard Ages

Child

Study Population

Breastfeeding infants and their mothers

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Carol L Cheatham, PhD	UNC at Chapel Hill	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nutrition Research Institute		Kannapolis	North Carolina	28081	United States