Text Size

Effect of the Level of Dietary Protein on Infant Growth

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT00716105
First received: July 11, 2008
Last updated: September 25, 2012
Last verified: September 2012
History of Changes
  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

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Nestlé:

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: November 2015
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control
Standard Infant Formula
 Other: Standard infant formula
From 3 to 12 months of age. As per standard requirement
Experimental: Test Product
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
No Intervention: Breast Milk
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
Iowa City, Iowa, United States, 52242
United States, Oklahoma
Department of Pediatrics University of Oklahoma Health Sciences
Oklahoma City, Oklahoma, United States, 73102
Sponsors and Collaborators
Nestlé
Investigators
Principal Investigator: Ekhard E Ziegler, MD The Samuel J. Fomon Infant Nutrition Unit Dept of Pediatrics, University of Iowa
  More Information

No publications provided

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT00716105     History of Changes
Other Study ID Numbers: 06.29.INF
Study First Received: July 11, 2008
Last Updated: September 25, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Nestlé:
Infant formula
Protein metabolism

ClinicalTrials.gov processed this record on June 18, 2013