The Evaluation of Cow Milk-Based Formulas

NCT ID: NCT00518414

Last Updated: 2015-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2008-01-31

Brief Summary

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

Detailed Description

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Conditions

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Term Infants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Marketed infant formula with DHA and ARA

Marketed milk-based infant formula containing docosahexaenoic acid (DHA) and arachidonic acid (ARA)

Group Type ACTIVE_COMPARATOR

Marketed infant formula with DHA and ARA

Intervention Type OTHER

Milk-based infant formula with DHA and ARA

Experimental milk-based infant formula containing docosahexaenoic acid (DHA) and arachidonic acid (ARA)

Group Type EXPERIMENTAL

Milk-based infant formula with DHA and ARA

Intervention Type OTHER

Milk-based formula with DHA, ARA, prebiotics

Experimental milk-based infant formula containing docosahexaenoic acid (DHA) and arachidonic acid (ARA) and prebiotic blend

Group Type EXPERIMENTAL

Milk-based formula with DHA, ARA, prebiotics

Intervention Type OTHER

Interventions

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Marketed infant formula with DHA and ARA

Intervention Type OTHER

Milk-based infant formula with DHA and ARA

Intervention Type OTHER

Milk-based formula with DHA, ARA, prebiotics

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Breast fed infants
* Infants with formula intolerance
Minimum Eligible Age

10 Days

Maximum Eligible Age

18 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mead Johnson Nutrition

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carol L Berseth, M.D.

Role: STUDY_DIRECTOR

Mead Johnson Nutritionals

Locations

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Birmingham Pediatric Group

Birmingham, Alabama, United States

Site Status

Southlake Pediatrics

Birmingham, Alabama, United States

Site Status

Arkansas Pediatric Clinic

Little Rock, Arkansas, United States

Site Status

Children's Medical Association

Tamarac, Florida, United States

Site Status

Welborn Clinic

Evansville, Indiana, United States

Site Status

The Center for Human Nutrition

Omaha, Nebraska, United States

Site Status

Holston Medical Group

Kingsport, Tennessee, United States

Site Status

DCOL Center for Clinical Research

Longview, Texas, United States

Site Status

Northwood Pediatrics

The Woodlands, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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3378

Identifier Type: -

Identifier Source: org_study_id

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