Healthy Term Infants Fed Milk-Based Formulas

Phase 3

Completed

• Conditions: Healthy Term Infant
• Interventions: Other: A powdered milk-based infant formula, standard fat blend; Other: Experimental powdered milk-based infant formula with an alternate fat blend

• Registration Number: NCT01617889
• Lead Sponsor: Abbott Nutrition

Brief Summary

The objective is to assess the comparative fat and calcium absorption, and gastrointestinal (GI) tolerance in healthy normal term infants fed powdered milk-based formulas containing different fat blends.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2012-06-10
• Study First Submitted QC: 2012-06-12
• Study First Posted: 2012-06-13
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-14
• Last Update Posted: 2013-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

• Infant is judged to be in good health.
• Infant is singleton from a full term birth
• Infant's birth weight was > 2490 g.
• Infant is between 53 and 115 days of age
• Infant is on infant formula and tolerating infant formula feedings
• Parent(s) confirm they will not administer vitamin or mineral supplements, solid foods or juices for the duration of the study, unless instructed otherwise by their healthcare professional.
• Parent(s) and physician agree to discontinue the use of medications or home remedies, herbal preparations that might affect GI tolerance

Exclusion Criteria

Infant has received human milk within 7 days prior to SDay 1.

Any adverse maternal, fetal or infant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development and includes maternal substance abuse

Infant has been treated with antibiotics within 5 days prior to SDay 1

Infant has received probiotics within 5 days prior to SDay 1.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Powdered milk-based formula, standard fat blend	A powdered milk-based infant formula, standard fat blend	-
Powder milk-based formula, alternate fat blend	Experimental powdered milk-based infant formula with an alternate fat blend	-

Primary Outcome Measures

Name	Time	Method
calcium absorption	8 days	as measured in stool

Secondary Outcome Measures

Name	Time	Method
percent of feedings with spit up/vomit associated with feeding per day.	28 days
stool consistency	28 days	measured on 5 point scale
fat absorption	8 days	as measured in stool
average number of stools per day	28 days

Trial Locations

Locations (1)

University of Colorado Denver; 🇺🇸 Aurora, Colorado, United States