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Clinical Trials/NCT01300000
NCT01300000
Completed
N/A

Effects of Early Nutrient Intake on Growth and Body Composition

Abbott Nutrition1 site in 1 country649 target enrollmentMarch 2010
ConditionsInfant Newborn

Overview

Phase
N/A
Intervention
Not specified
Conditions
Infant Newborn
Sponsor
Abbott Nutrition
Enrollment
649
Locations
1
Primary Endpoint
Weight gain
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
March 2010
End Date
August 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Weight gain

Time Frame: 1- 365 days

Secondary Outcomes

  • Gastrointestinal tolerance(1-365 days)
  • Infant Anthropometrics(1 - 365 days; 24 months)

Study Sites (1)

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