Healthy Term Infants Fed Milk-Based Formulas With Different Fat Blends

Abbott Nutrition1 site in 1 country17 target enrollmentMarch 2011

ConditionsHealthy Term Infant

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Healthy Term Infant
Sponsor: Abbott Nutrition
Enrollment: 17
Locations: 1
Primary Endpoint: calcium absorption
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2011

End Date

August 2012

Last Updated

13 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Abbott Nutrition

Responsible Party

Sponsor

Eligibility Criteria

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
•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.

Outcomes

Primary Outcomes

calcium absorption

Time Frame: 8 days

as measured in stool

Secondary Outcomes

percent of feedings with spit up/vomit associated with feeding per day.(28 days)
stool consistency(28 days)
fat absorption(8 days)
average number of stools per day(28 days)