The Evaluation of Cow Milk-Based Formulas

September 24, 2015 updated by: Mead Johnson Nutrition

The Evaluation of Cow Milk-Based Formulas - Study A

Infants will be fed infant formula and blood drawn to measure fatty acid levels in the blood.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

136

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
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Birmingham Pediatric Group
      • Birmingham, Alabama, United States, 35244
        • Southlake Pediatrics
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Arkansas Pediatric Clinic
    • Florida
      • Tamarac, Florida, United States, 33321
        • Children's Medical Association
    • Indiana
      • Evansville, Indiana, United States, 47714
        • Welborn Clinic
    • Nebraska
      • Omaha, Nebraska, United States, 68105
        • The Center for Human Nutrition
    • Tennessee
      • Kingsport, Tennessee, United States, 37660
        • Holston Medical Group
    • Texas
      • Longview, Texas, United States, 75605
        • DCOL Center for Clinical Research
      • The Woodlands, Texas, United States, 77380
        • Northwood Pediatrics

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

1 week to 2 weeks (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy, term infant
  • 10 to 18 days of age

Exclusion Criteria:

  • Breast fed infants
  • Infants with formula intolerance

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

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Marketed infant formula with DHA and ARA
Marketed milk-based infant formula containing docosahexaenoic acid (DHA) and arachidonic acid (ARA)
Other: Marketed infant formula with DHA and ARA
Experimental: Milk-based infant formula with DHA and ARA
Experimental milk-based infant formula containing docosahexaenoic acid (DHA) and arachidonic acid (ARA)
Other: Milk-based infant formula with DHA and ARA
Experimental: Milk-based formula with DHA, ARA, prebiotics
Experimental milk-based infant formula containing docosahexaenoic acid (DHA) and arachidonic acid (ARA) and prebiotic blend
Other: Milk-based formula with DHA, ARA, prebiotics

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Red Blood Cell (RBC) ARA and DHA
Time Frame: 120 Days of age
120 Days of age

Secondary Outcome Measures

Outcome Measure
Time Frame
Phospholipid fatty acids, tolerance
Time Frame: 120 Days of age
120 Days of age

Collaborators and Investigators

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

Sponsor

Mead Johnson Nutrition

Investigators

  • Study Director: Carol L Berseth, M.D., Mead Johnson Nutritionals

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

April 1, 2007

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

August 17, 2007

First Submitted That Met QC Criteria

August 17, 2007

First Posted (Estimate)

August 20, 2007

Study Record Updates

Last Update Posted (Estimate)

September 28, 2015

Last Update Submitted That Met QC Criteria

September 24, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 3378

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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