Healthy Term Infants Fed Milk-Based Formulas With A Supplemental Carotenoid

Abbott Nutrition6 sites in 1 country91 target enrollmentFebruary 2014

ConditionsInfants

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Infants
Sponsor: Abbott Nutrition
Enrollment: 91
Locations: 6
Primary Endpoint: Carotenoid Concentration
Status: Terminated
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a prospective, double blind, crossover study in healthy infants randomized to one of two study formulas. The trial will consist of two 21 day study feeding periods separated by a study washout period.

Registry

clinicaltrials.gov

Start Date

February 2014

End Date

February 2015

Last Updated

11 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Abbott Nutrition

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Infant is in good health
•Infant is a singleton from a full term birth with a gestational age of 37-42 weeks
•Infant's birth weight was \> 2490 g (\~5 lbs 8 oz)
•Infant is between 14 and 28 days of age
•Parent(s) confirm intention to feed their infant the study product(s) as the sole source of nutrition for the duration of the study
•Parent(s) confirm intention not to administer vitamin or mineral supplements, DHA and ARA supplements, solid foods/juices to their infant from enrollment through the duration of the study

Exclusion Criteria

•An adverse maternal, fetal or infant medical history that has potential for effects on tolerance, growth, and/or development.
•Infants using medications (including OTC), home remedies, herbal preparations, probiotics or rehydration fluids that might affect gastrointestinal (GI) tolerance