Healthy Term Infants Fed Milk-Based Formulas | NCT01617889

Studies
Healthy Term Infants Fed Milk-Based Formulas

NCT01617889

Sponsor

Abbott Nutrition

Status

Completed

Last Update Posted

Feb 15, 2013Estimated

Enrollment

17Actual

Phase

Phase 3

Conditions

Healthy Term Infant

Interventions

Experimental powdered milk-based infant formula with an alternate fat blend
A powdered milk-based infant formula, standard fat blend

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

Feb 2013

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

Mar 2011

Primary Completion Date

Aug 2012Actual

Completion Date

Aug 2012Actual

First Submitted Date

Jun 10, 2012

First Submission Date that Met QC Criteria

Jun 12, 2012

First Posted Date

Jun 13, 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

Feb 14, 2013

Last Update Posted Date

Feb 15, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The objective is to assess the comparative fat and calcium absorption, and gastrointestinal (GI) tolerance in healthy normal term infants fed powdered milk-based formulas containing different fat blends.

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

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

17Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Powdered milk-based formula, standard fat blend	Active Comparator		Other: A powdered milk-based infant formula, standard fat blend
Powder milk-based formula, alternate fat blend	Experimental		Other: Experimental powdered milk-based infant formula with an alternate fat blend

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Experimental powdered milk-based infant formula with an alternate fat blend	Other	formula to be consumed ad lib	Powder milk-based formula, alternate fat blend

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
calcium absorption	as measured in stool	8 days

Secondary Outcomes

Measure	Description	Time Frame
stool consistency	measured on 5 point scale	28 days
fat absorption	as measured in stool	8 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Infant is judged to be in good health.
Infant is singleton from a full term birth
Infant's birth weight was > 2490 g.
Infant is between 53 and 115 days of age
Infant is on infant formula and tolerating infant formula feedings
Parent(s) confirm they will not administer vitamin or mineral supplements, solid foods or juices for the duration of the study, unless instructed otherwise by their healthcare professional.
Parent(s) and physician agree to discontinue the use of medications or home remedies, herbal preparations that might affect GI tolerance

Exclusion Criteria:

Infant has received human milk within 7 days prior to SDay 1.

Any adverse maternal, fetal or infant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development and includes maternal substance abuse

Infant has been treated with antibiotics within 5 days prior to SDay 1

Infant has received probiotics within 5 days prior to SDay 1.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

53 Days

Maximum Age

115 Days

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided