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Effect of the Level of Dietary Protein on Infant Growth

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00716105
First Posted: July 16, 2008
Last Update Posted: May 19, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Nestlé
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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:


Further study details as provided by Nestlé:

Primary Outcome Measures:
  • Mean weight gain [ Time Frame: 6 months ]

Enrollment: 405
Study Start Date: August 2008
Study Completion Date: February 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   3 Months to 12 Months   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT00716105     History of Changes
Other Study ID Numbers: 06.29.INF
First Submitted: July 11, 2008
First Posted: July 16, 2008
Last Update Posted: May 19, 2015
Last Verified: October 2014

Keywords provided by Nestlé:
Infant formula
Protein metabolism