Growth and Safety of a Low Lactose Milk-Based Infant Formula | NCT01497314

Studies
Growth and Safety of a Low Lactose Milk-Based Infant Formula

NCT01497314

Sponsor

Perrigo Nutritionals

Status

Completed

Last Update Posted

May 15, 2013Estimated

Enrollment

85Actual

Phase

Not Applicable

Conditions

Growth
Healthy Term Infants

Interventions

Low Lactose Infant Formula

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

May 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

Dec 2011

Primary Completion Date

Mar 2013Actual

Completion Date

Mar 2013Actual

First Submitted Date

Dec 15, 2011

First Submission Date that Met QC Criteria

Dec 19, 2011

First Posted Date

Dec 22, 2011Estimated

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

May 14, 2013

Last Update Posted Date

May 15, 2013Estimated

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

The purpose of this study is to show that a low lactose milk-based infant formula supports normal growth in healthy term infants.

Detailed Description

Infants will be fed a low lactose milk-based formula for 16 weeks. Growth and formula tolerability will be assessed.

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

85Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Low Lactose Infant Formula	Other		Other: Low Lactose Infant Formula

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Low Lactose Infant Formula	Other	Low Lactose Infant Formula	Low Lactose Infant Formula

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Weight		16 weeks

Secondary Outcomes

Measure	Description	Time Frame
Length gain		16 weeks
Occipital Head Circumference		16 weeks
Acceptability and Tolerability

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

healthy term infants
birth weight 2500 - 4500 g
singleton birth
37 - 42 weeks gestation

Exclusion Criteria:

clinically significant abnormal findings (as determined by the investigator) on the physical examination or medical history
receiving medications other than vitamins

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

14 Days

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Cynthia M Barber, PhD	Perrigo Nutritionals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Accelovance Melbourne Site		Melbourne	Florida	23935	United States
ACC Pediatric Research