Growth and Tolerance of Cow Milk-Based Infant Formulas

NCT ID: NCT01122654

Last Updated: 2012-01-31

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

COMPLETED

Total Enrollment

405 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-07-31

Study Completion Date

2011-12-31

Brief Summary

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This clinical trial will assess growth, tolerance and adverse events of cow milk-based infant formulas in healthy, term infants.

Detailed Description

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Conditions

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Body Weight

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Control

No interventions assigned to this group

Experimental 1

No interventions assigned to this group

Experimental 2

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Singleton, 12-16 days of age at randomization
* Term infant with birth weight of minimum of 2500 g
* Solely formula fed
* Signed Informed Consent and Protected Health Information

Exclusion Criteria

* History of underlying metabolic or chronic disease or immunocompromised
* Acute infection
* Feeding difficulties or formula intolerance
Minimum Eligible Age

12 Days

Maximum Eligible Age

16 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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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

Pediatrics East - Alabama Clinical Therapeutics

Pinson, Alabama, United States

Site Status

Central Arkansas Pediatric Clinic

Benton, Arkansas, United States

Site Status

Arkansas Pediatric Clinic

Little Rock, Arkansas, United States

Site Status

Norwich Pediatric Group, PC

Norwich, Connecticut, United States

Site Status

Altamonte Pediatric Associates

Lake Mary, Florida, United States

Site Status

Children's Medical Association

Plantation, Florida, United States

Site Status

North Georgia Clinical Research Center/White's Pediatrics

Dalton, Georgia, United States

Site Status

Deaconess Clinic Gateway

Newburgh, Indiana, United States

Site Status

PTCU/Children & Youth Project

Louisville, Kentucky, United States

Site Status

Owensboro Pediatrics

Owensboro, Kentucky, United States

Site Status

Woburn Pediatric Associates

Woburn, Massachusetts, United States

Site Status

Southwestern Medical Clinic, PC

Niles, Michigan, United States

Site Status

Southwestern Medical Clinic P.C.

Stevensville, Michigan, United States

Site Status

The Center for Human Nutrition

Omaha, Nebraska, United States

Site Status

Cary Pediatric Center, PA

Cary, North Carolina, United States

Site Status

Innovis Health South University

Fargo, North Dakota, United States

Site Status

Red Lion Pediatrics

Philadelphia, Pennsylvania, United States

Site Status

Primary Physicians Research, Inc

Pittsburgh, Pennsylvania, United States

Site Status

Alpha Clinical Research

Clarksville, Tennessee, United States

Site Status

The Jackson Clinic - North Jackson

Jackson, Tennessee, United States

Site Status

Holston Medical Group

Kingsport, Tennessee, United States

Site Status

Austin Diagnostic Clinic

Austin, Texas, United States

Site Status

Countries

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United States

References

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Johnston WH, Ashley C, Yeiser M, Harris CL, Stolz SI, Wampler JL, Wittke A, Cooper TR. Growth and tolerance of formula with lactoferrin in infants through one year of age: double-blind, randomized, controlled trial. BMC Pediatr. 2015 Nov 7;15:173. doi: 10.1186/s12887-015-0488-3.

Reference Type DERIVED
PMID: 26547414 (View on PubMed)

Other Identifiers

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3380-1

Identifier Type: -

Identifier Source: org_study_id

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