NCT00665938

Brief Summary

The purpose of this study is to compare physical development of infants fed one of three study formulas.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
183

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Oct 2006

Longer than P75 for not_applicable healthy

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 28, 2008

Completed
27 days until next milestone

First Posted

Study publicly available on registry

April 24, 2008

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

January 31, 2012

Status Verified

January 1, 2012

Enrollment Period

5.2 years

First QC Date

March 28, 2008

Last Update Submit

January 27, 2012

Conditions

Healthy

Keywords

Physical development

Outcome Measures

Primary Outcomes (1)

  • Achieved weight

    5 years

Secondary Outcomes (1)

  • Tolerance

    1 year

Study Arms (3)

1

ACTIVE COMPARATOR
Other: Infant formula

2

EXPERIMENTAL
Other: Infant formula

3

EXPERIMENTAL
Other: Infant formula

Interventions

Infant formulaOTHER

Arm 1. extensively hydrolyzed infant formula without probiotics (Nutramigen LIPIL) Arm 2. partially hydrolyzed infant formula with probiotics Arm 3. extensively hydrolyzed infant formula with probiotics

Also known as: No other names are applicable to the 3 intervention arms
123

Eligibility Criteria

Age4 Months - 4 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Completed Study 3369-5

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Infant Formula

Intervention Hierarchy (Ancestors)

Milk SubstitutesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood, FormulatedFoods, SpecializedFoodInfant FoodFood and Beverages

Study Officials

  • Deolinda Scalabrin, MD

    Mead Johnson Nutrition

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 28, 2008

First Posted

April 24, 2008

Study Start

October 1, 2006

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

January 31, 2012

Record last verified: 2012-01