Growth and Tolerance of Healthy Term Infants Fed Cow's Milk-Based Infant Formulas

NCT ID: NCT02860026

Last Updated: 2017-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2018-04-30

Brief Summary

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This clinical trial will compare the growth and tolerance of infants who consume an investigational cow's milk-based infant formula to those who consume a marketed cow's milk-based infant formula through approximately 4 months of age.

Detailed Description

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Conditions

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Growth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Control

Marketed cow's milk-based infant formula

Group Type ACTIVE_COMPARATOR

Marketed cow's milk-based infant formula

Intervention Type OTHER

Investigational

Cow's milk-based infant formula with added nutrients

Group Type EXPERIMENTAL

Cow's milk-based infant formula with added nutrients

Intervention Type OTHER

Interventions

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Marketed cow's milk-based infant formula

Intervention Type OTHER

Cow's milk-based infant formula with added nutrients

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Singleton 10-14 days of age at randomization
* Term infant with birth weight of minimum of 2500 grams
* Solely formula fed
* Signed informed consent and protected health information

Exclusion Criteria

* History of underlying metabolic or chronic disease, anemia, or immune compromise
* Feeding difficulties or formula intolerance
Minimum Eligible Age

10 Days

Maximum Eligible Age

14 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mead Johnson Nutrition

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Steven Wu

Role: STUDY_DIRECTOR

Mead Johnson Nutrition

Locations

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Birmingham Pediatric Associates

Birmingham, Alabama, United States

Site Status

Southeastern Pediatric Associates

Dothan, Alabama, United States

Site Status

Northwest Arkansas Pediatric Clinic

Fayetteville, Arkansas, United States

Site Status

The Children's Clinic of Jonesboro, P.A.

Jonesboro, Arkansas, United States

Site Status

Norwich Pediatric Group, P.C.

Norwich, Connecticut, United States

Site Status

Altamonte Pediatric Associates

Lake Mary, Florida, United States

Site Status

Deaconess Clinical Research

Evansville, Indiana, United States

Site Status

Kentucky Pediatrics/Adult Research

Bardstown, Kentucky, United States

Site Status

Owensboro Pediatrics

Owensboro, Kentucky, United States

Site Status

Pediatric Associates of Mt. Carmel, Inc.

Cincinnati, Ohio, United States

Site Status

Ohio Pediatric Research Association

Dayton, Ohio, United States

Site Status

Pediatric Associates of Fairfield, Inc.

Fairfield, Ohio, United States

Site Status

UHMP Comprehensive Pediatrics

Westlake, Ohio, United States

Site Status

Coastal Pediatric Research

Charleston, South Carolina, United States

Site Status

The Jackson Clinic - North Jackson

Jackson, Tennessee, United States

Site Status

Holston Medical Group

Kingsport, Tennessee, United States

Site Status

DCOL Center for Clinical Research

Longview, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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3388-1

Identifier Type: -

Identifier Source: org_study_id

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