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The Evaluation of Cow Milk-Based Formulas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00518414
Recruitment Status : Completed
First Posted : August 20, 2007
Last Update Posted : September 28, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Infants will be fed infant formula and blood drawn to measure fatty acid levels in the blood.

Condition or disease Intervention/treatment
Term Infants Other: Marketed infant formula with DHA and ARA Other: Milk-based infant formula with DHA and ARA Other: Milk-based formula with DHA, ARA, prebiotics

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: The Evaluation of Cow Milk-Based Formulas - Study A
Study Start Date : April 2007
Primary Completion Date : January 2008
Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Red Blood Cell (RBC) ARA and DHA [ Time Frame: 120 Days of age ]

Secondary Outcome Measures :
  1. Phospholipid fatty acids, tolerance [ Time Frame: 120 Days of age ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Breast fed infants
  • Infants with formula intolerance
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00518414


Locations
United States, Alabama
Birmingham Pediatric Group
Birmingham, Alabama, United States, 35205
Southlake Pediatrics
Birmingham, Alabama, United States, 35244
United States, Arkansas
Arkansas Pediatric Clinic
Little Rock, Arkansas, United States, 72205
United States, Florida
Children's Medical Association
Tamarac, Florida, United States, 33321
United States, Indiana
Welborn Clinic
Evansville, Indiana, United States, 47714
United States, Nebraska
The Center for Human Nutrition
Omaha, Nebraska, United States, 68105
United States, Tennessee
Holston Medical Group
Kingsport, Tennessee, United States, 37660
United States, Texas
DCOL Center for Clinical Research
Longview, Texas, United States, 75605
Northwood Pediatrics
The Woodlands, Texas, United States, 77380
Sponsors and Collaborators
Mead Johnson Nutrition
Investigators
Study Director: Carol L Berseth, M.D. Mead Johnson Nutritionals
More Information

Responsible Party: Mead Johnson Nutrition
ClinicalTrials.gov Identifier: NCT00518414     History of Changes
Other Study ID Numbers: 3378
First Posted: August 20, 2007    Key Record Dates
Last Update Posted: September 28, 2015
Last Verified: September 2015

Keywords provided by Mead Johnson Nutrition:
infant, formula, LC PUFA