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Evaluation of Cow Milk-Based Formulas - Functional Proteins

This study has been completed.
Sponsor:
Information provided by:
Mead Johnson Nutrition
ClinicalTrials.gov Identifier:
NCT00916565
First received: June 5, 2009
Last updated: August 31, 2011
Last verified: August 2011
History of Changes
  Purpose

The purpose of this study is to look at the function of infant formula components to optimize the nutritional content and functionality of a marketed routine infant formula.


Condition
Healthy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Evaluation of Cow Milk-Based Formulas - Functional Proteins

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mead Johnson Nutrition:

Estimated Enrollment: 139
Study Start Date: July 2009
Groups/Cohorts
Experimental milk-based infant formula
Control milk-based infant formula
Breastfed Reference Group

  Eligibility

Ages Eligible for Study:   up to 18 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

formula-fed and breastfed infants

Criteria

Inclusion Criteria:

  • 10-18 days of age
  • 37-42 weeks gestation
  • birth weight 2500 g or more
  • consuming one source of nutrition

Exclusion Criteria:

  • metabolic or chronic disease
  • acute infection
  • feeding difficulties
  • consumed complementary foods or donor milk
  • steroid use
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00916565

Locations
United States, Alabama
Dr. Claude Ashley
Birmingham, Alabama, United States, 35235
William Johnston, MD
Birmingham, Alabama, United States, 35235
United States, Arkansas
Lori Montgomery, MD
Little Rock, Arkansas, United States, 72205
United States, Florida
Edward Zissman, MD
Lake Mary, Florida, United States, 32746
Harold Deulofeut MD
Plantation, Florida, United States, 33324
Harold Deulofeut MD
Tamarac, Florida, United States, 33321
United States, Kansas
Susan Carlson, Ph.D.
Kansas City, Kansas, United States, 66160
United States, Massachusetts
Joseph Leader, MD
Woburn, Massachusetts, United States, 01801
United States, Nebraska
Ann Grandjean, Ed. D
Omaha, Nebraska, United States, 68105
United States, Tennessee
Laurie Harris-Ford, MD
Clarksville, Tennessee, United States, 37043
United States, Texas
Beth Nauert, MD
Austin, Texas, United States, 78745
Sponsors and Collaborators
Mead Johnson Nutrition
  More Information

No publications provided

Responsible Party: Bryan Liu, Mead Johnson Nutrition
ClinicalTrials.gov Identifier: NCT00916565     History of Changes
Other Study ID Numbers: 3378-3
Study First Received: June 5, 2009
Last Updated: August 31, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Mead Johnson Nutrition:
optimize nutritional content of infant formula
Infant

ClinicalTrials.gov processed this record on June 18, 2013