NCT01699386
Completed
Phase 3
Growth of Infants Fed an Elemental Medical Food
ConditionsHealthy Infants
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Healthy Infants
- Sponsor
- Abbott Nutrition
- Enrollment
- 213
- Locations
- 2
- Primary Endpoint
- Weight
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
Effects on weight will be monitored in healthy infant subjects consuming assigned infant formulas.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Singleton, healthy infant
- •Gestational age of 37 to 42 weeks
- •Birth weight of 2500 grams or greater
- •Age between birth and 9 days of age
- •Parents agree to not administer mineral or vitamin supplements during the study period
- •Parents agree to feed study formula exclusively for the duration of the study
Exclusion Criteria
- •Maternal, fetal or perinatal history which may have adverse effects on growth
- •Multiple birth
Outcomes
Primary Outcomes
Weight
Time Frame: 14 days of age to 112 days of age
weight gain during the study period
Secondary Outcomes
- Lab Measurement(At 112 day visit)
- Anthropometric Measurements(14 days of age to 112 days of age)
- GI Tolerance(At visits 14 and 28)
Study Sites (2)
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