Effect of the Level of Dietary Protein on Infant Growth
1 other identifier
interventional
405
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2008
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 11, 2008
CompletedFirst Posted
Study publicly available on registry
July 16, 2008
CompletedStudy Start
First participant enrolled
August 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedMay 19, 2015
October 1, 2014
1.9 years
July 11, 2008
May 18, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean weight gain
6 months
Study Arms (3)
Control
PLACEBO COMPARATORStandard Infant Formula
Test Product
EXPERIMENTALInfant formula with different level of proteins
Breast Milk
NO INTERVENTIONBreastfeeding reference group
Interventions
From 3 to 12 months of age. As per standard requirement
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
The Samuel J. Fomon Infant Nutrition Unit Dept of Pediatrics, University of Iowa
Iowa City, Iowa, 52242, United States
Department of Pediatrics University of Oklahoma Health Sciences
Oklahoma City, Oklahoma, 73102, United States
Related Publications (1)
Ziegler EE, Fields DA, Chernausek SD, Steenhout P, Grathwohl D, Jeter JM, Nelson SE, Haschke F. Adequacy of Infant Formula With Protein Content of 1.6 g/100 kcal for Infants Between 3 and 12 Months. J Pediatr Gastroenterol Nutr. 2015 Nov;61(5):596-603. doi: 10.1097/MPG.0000000000000881.
PMID: 26154030DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ekhard E Ziegler, MD
The Samuel J. Fomon Infant Nutrition Unit Dept of Pediatrics, University of Iowa
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 11, 2008
First Posted
July 16, 2008
Study Start
August 1, 2008
Primary Completion
July 1, 2010
Study Completion
February 1, 2015
Last Updated
May 19, 2015
Record last verified: 2014-10