Plasma Profile of Exclusively Breastfed Infants | NCT01669655

Studies
Plasma Profile of Exclusively Breastfed Infants

NCT01669655

Sponsor

Abbott Nutrition

Status

Completed

Last Update Posted

Jan 21, 2015Estimated

Enrollment

56Actual

Phase

Not provided

Conditions

Breast Fed Infants

Interventions

Not provided

Countries

China

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

Jan 2015

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

Jun 2012

Primary Completion Date

Nov 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Aug 16, 2012

First Submission Date that Met QC Criteria

Aug 17, 2012

First Posted Date

Aug 21, 2012Estimated

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

Jan 19, 2015

Last Update Posted Date

Jan 21, 2015Estimated

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

To characterize nutrient levels in breastfeeding infants and their mothers.

Detailed Description

The objectives of this study are (1) to characterize plasma lutein levels in breastfed infants in an Asian population where lactating mothers have diets habitually high in lutein and (2) investigate how blood lutein levels in breastfed infants vary according to lutein content of the mothers' milk in such a population.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

56Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Plasma carotenoids in breastfed infants		At visit 1 (enrollment)

Secondary Outcomes

Measure	Description	Time Frame
Plasma carotenoids in mothers of breastfed infants		At visit 1 (enrollment)
Dietary carotenoid intake of mothers of breastfed infants		At visit 1 (enrollment) and visit 2 (14 days)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Infant is judged to be in good health.
Infant is a singleton from a full term birth.
Infant's birth weight was > 2490 g.
Infant is between 6 weeks and 16 weeks (42 to 112 days).
Infant must have been exclusively breastfed at enrollment.
Mother's intake indicates a consumption of an average of at least three servings of fruit and/or vegetables per day.
Mother is a non-smoker.
Mother is in good health.
Mother confirms her intention to continue breastfeeding.

Exclusion Criteria:

An adverse maternal, fetal or infant medical history that is thought to have potential for effects on growth, and/or development.
Infants who have consumed medications or herbal preparations during past 14 days prior to enrollment.
Infants who have consumed any solid or liquid foods or juices prior to enrollment.
Infants who have received any supplements containing carotenoids prior to enrollment.
Mother who is consuming dietary supplements containing carotenoids.
Participation in another study that has not been approved as a concomitant study.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Weeks

Maximum Age

16 Weeks

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
Xianfeng Zhao, MD, PhD	Abbott Nutrition, R&D China	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fudan University of Shanghai		Shanghai	Shanghai Municipality		China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30204542	Derived	Xu X, Zhao X, Berde Y, Low YL, Kuchan MJ. Milk and Plasma Lutein and Zeaxanthin Concentrations in Chinese Breast-Feeding Mother-Infant Dyads With Healthy Maternal Fruit and Vegetable Intake. J Am Coll Nutr. 2019 Feb;38(2):179-184. doi: 10.1080/07315724.2018.1490934. Epub 2018 Sep 11.

ID	Term
D005247	Feeding Behavior
D001519	Behavior