This trial is active, not recruiting.

Condition infant newborn
Treatments human milk, investigational infant formula, milk based standard infant formula
Phase phase 3
Sponsor Abbott Nutrition
Collaborator Institute of Child Health
Start date March 2010
End date September 2013
Trial size 649 participants
Trial identifier NCT01300000, AK65


The primary objective of the study is to compare the growth of infants fed standard infant formula with infants fed a reduced calorie and protein formula.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
(Active Comparator)
ad lib
human milk
ad lib
(Active Comparator)
ad lib
milk based standard infant formula
ad lib
ad lib
investigational infant formula
ad lib

Primary Outcomes

Weight gain
time frame: 1- 365 days

Secondary Outcomes

Gastrointestinal tolerance
time frame: 1-365 days
Infant Anthropometrics
time frame: 1 - 365 days; 24 months

Eligibility Criteria

Male or female participants up to 24 hours old.

Inclusion Criteria: - good health - singleton birth with gestational age 37-42 weeks - infant's birth weight >or = to 2500 grams - exclusive breastfeeding or exclusively formula feeding - within a defined geographical boundary - mother has no problems communicating in English Exclusion Criteria: - adverse maternal, fetal or infant medical history - congenital disease or malformation affecting growth or development - illness or social problems in mother or infant - temporary residents

Additional Information

Official title Effects of Early Nutrient Intake on Growth and Body Composition
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Abbott Nutrition.