Healthy Term Infants Fed Milk-Based Formulas | NCT02069522

Studies
Healthy Term Infants Fed Milk-Based Formulas

NCT02069522

Sponsor

Abbott Nutrition

Status

Terminated

Last Update Posted

Mar 24, 2015Estimated

Enrollment

91Actual

Phase

Not Applicable

Conditions

Infants

Interventions

Standard Milk-based Formula Containing Carotenoid
Investigational Milk-based Formula Containing Carotenoid

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

Mar 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

interim analysis findings

Expanded Access Info

Start Date

Feb 2014

Primary Completion Date

Feb 2015Actual

Completion Date

Feb 2015Actual

First Submitted Date

Feb 18, 2014

First Submission Date that Met QC Criteria

Feb 20, 2014

First Posted Date

Feb 24, 2014Estimated

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

Mar 20, 2015

Last Update Posted Date

Mar 24, 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

This is a prospective, double blind, crossover study in healthy infants randomized to one of two study formulas. The trial will consist of two 21 day study feeding periods separated by a study washout period.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

91Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Standard Milk-based Formula Containing Carotenoid	Active Comparator	milk-based ready to feed infant formula	Other: Standard Milk-based Formula Containing Carotenoid
Investigational Milk-based Formula Containing Carotenoid	Experimental	investigational milk-based ready to feed infant formula	Other: Investigational Milk-based Formula Containing Carotenoid

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Standard Milk-based Formula Containing Carotenoid	Other	Fed ad libitum	Standard Milk-based Formula Containing Carotenoid

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Carotenoid Concentration	Plasma sample	Change from Baseline to end of Study Period A (~21 Days)

Secondary Outcomes

Measure	Description	Time Frame
Carotenoid Concentration	Plasma sample	Change from Baseline to end Study Periods A (~21 Days) and B (~21 Days)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Infant is in good health
Infant is a singleton from a full term birth with a gestational age of 37-42 weeks
Infant's birth weight was > 2490 g (~5 lbs 8 oz)
Infant is between 14 and 28 days of age
Parent(s) confirm intention to feed their infant the study product(s) as the sole source of nutrition for the duration of the study
Parent(s) confirm intention not to administer vitamin or mineral supplements, DHA and ARA supplements, solid foods/juices to their infant from enrollment through the duration of the study

Exclusion Criteria:

An adverse maternal, fetal or infant medical history that has potential for effects on tolerance, growth, and/or development.
Infants using medications (including OTC), home remedies, herbal preparations, probiotics or rehydration fluids that might affect gastrointestinal (GI) tolerance

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Days

Maximum Age

28 Days

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
John B Lasekan, PhD, CCRP	Abbott Nutrition	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tuscon Medical Center		Tuscon	Arizona	85712	United States
Northpoint Pediatrics