Effect of the Level of Dietary Protein on Infant Growth - Full Text View

Sponsored by:	Nestlé Nutrition Corporate
Information provided by:	Nestlé Nutrition Corporate
ClinicalTrials.gov Identifier:	NCT00716105

Purpose

The purpose of this study is to determine whether infants fed a formula with protein levels different than a standard infant formula have similar growth and development.

Condition	Intervention
Infant Nutrition	Other: Standard infant formula Other: Infant formula with different level of proteins

MedlinePlus related topics: Children's Health Dietary Proteins Infant and Toddler Nutrition

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Effect of the Level of Dietary Protein on Infant Growth and Body Composition in the First Year of Life

Further study details as provided by Nestlé Nutrition Corporate:

Primary Outcome Measures:

Mean weight gain [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	405
Study Start Date:	August 2008
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Control: Placebo Comparator Standard Infant Formula	Other: Standard infant formula From 3 to 12 months of age. As per standard requirement
Test Product: Experimental Infant formula with different level of proteins	Other: Infant formula with different level of proteins From 3 to 12 months of age. As per standard requirement
Breast Milk: No Intervention Breastfeeding reference group

Eligibility

Ages Eligible for Study:	3 Months to 12 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Gestational age at least 37 weeks
Singleton birth
Birth weight between 2500g and 4500g
Weight at enrolment is at or above the 5th percentile (CDC)
Infant has been exclusively formula fed for at least the last 14 days
Having obtained informed consent of legal representative

Exclusion Criteria:

Congenital illness or malformation that affects infant feeding and/or growth
Significant pre-natal and/or post-natal disease
Suspected or confirmed allergy to cow milk protein
In the investigators assessment, infant's family cannot be expected to comply with treatment (feeding regimen)
Currently participating in another clinical trial

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00716105

Locations

United States, Iowa
The Samuel J. Fomon Infant Nutrition Unit Dept of Pediatrics, University of Iowa	Recruiting
Iowa City, Iowa, United States, 52242
Contact: Ekhard E Ziegler, MD 319-335-4570 ekhard-ziegler@uiowa.edu
United States, Oklahoma
Department of Pediatrics University of Oklahoma Health Sciences	Recruiting
Oklahoma City, Oklahoma, United States, 73102
Contact: David Fields, PhD 405-271-8001 ext 43083 dfields@ouhsc.edu

Sponsors and Collaborators

Nestlé Nutrition Corporate

Investigators

Principal Investigator:

Ekhard E Ziegler, MD

The Samuel J. Fomon Infant Nutrition Unit Dept of Pediatrics, University of Iowa

More Information

Responsible Party:	The Samuel J. Fomon Infant Nutrition Unit Dept of Pediatrics, University of Iowa ( Ekhard E. Ziegler, MD )
Study ID Numbers:	06.29.INF
Study First Received:	July 11, 2008
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00716105
Health Authority:	United States: Institutional Review Board

Keywords provided by Nestlé Nutrition Corporate:

Infant formula
Protein metabolism

ClinicalTrials.gov processed this record on January 16, 2009