Healthy Term Infants Fed Milk-Based Formulas

March 20, 2015 updated by: Abbott Nutrition

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

91

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tuscon, Arizona, United States, 85712
        • Tuscon Medical Center
    • Indiana
      • Indianapolis, Indiana, United States, 46256
        • Northpoint Pediatrics
    • Nebraska
      • Lincoln, Nebraska, United States, 68505
        • Midwest Children's Health Research Institute
    • Ohio
      • Cleveland, Ohio, United States, 44109
        • MetroHealth Medical Center
      • Dayton, Ohio, United States, 45406
        • Dayton Clinical Research
      • Mayfield Heights, Ohio, United States, 44143
        • Institute of Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 weeks to 4 weeks (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard Milk-based Formula Containing Carotenoid
milk-based ready to feed infant formula
Other: Standard Milk-based Formula Containing Carotenoid
Fed ad libitum
Experimental: Investigational Milk-based Formula Containing Carotenoid
investigational milk-based ready to feed infant formula
Other: Investigational Milk-based Formula Containing Carotenoid
Fed ad libitum

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Carotenoid Concentration
Time Frame: Change from Baseline to end of Study Period A (~21 Days)
Plasma sample
Change from Baseline to end of Study Period A (~21 Days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Carotenoid Concentration
Time Frame: Change from Baseline to end Study Periods A (~21 Days) and B (~21 Days)
Plasma sample
Change from Baseline to end Study Periods A (~21 Days) and B (~21 Days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Nutrition

Investigators

  • Study Chair: John B Lasekan, PhD, CCRP, Abbott Nutrition

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

February 18, 2014

First Submitted That Met QC Criteria

February 20, 2014

First Posted (Estimate)

February 24, 2014

Study Record Updates

Last Update Posted (Estimate)

March 24, 2015

Last Update Submitted That Met QC Criteria

March 20, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AL13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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