Healthy Term Infants Fed Milk-Based Formulas

Not Applicable

Terminated

• Conditions: Infants
• Interventions: Other: Standard Milk-based Formula Containing Carotenoid; Other: Investigational Milk-based Formula Containing Carotenoid

• Registration Number: NCT02069522
• Lead Sponsor: Abbott Nutrition

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-02-18
• Study First Submitted QC: 2014-02-20
• Study First Posted: 2014-02-24
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-20
• Last Update Posted: 2015-03-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 91

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Standard Milk-based Formula Containing Carotenoid	Standard Milk-based Formula Containing Carotenoid	milk-based ready to feed infant formula
Investigational Milk-based Formula Containing Carotenoid	Investigational Milk-based Formula Containing Carotenoid	investigational milk-based ready to feed infant formula

Primary Outcome Measures

Name	Time	Method
Carotenoid Concentration	Change from Baseline to end of Study Period A (~21 Days)	Plasma sample

Secondary Outcome Measures

Name	Time	Method
Carotenoid Concentration	Change from Baseline to end Study Periods A (~21 Days) and B (~21 Days)	Plasma sample

Trial Locations

Locations (6)

Midwest Children's Health Research Institute; 🇺🇸 Lincoln, Nebraska, United States

MetroHealth Medical Center; 🇺🇸 Cleveland, Ohio, United States

Northpoint Pediatrics; 🇺🇸 Indianapolis, Indiana, United States

Institute of Clinical Research; 🇺🇸 Mayfield Heights, Ohio, United States

Tuscon Medical Center; 🇺🇸 Tuscon, Arizona, United States

Dayton Clinical Research; 🇺🇸 Dayton, Ohio, United States