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The Evaluation of Cow Milk-Based Formulas

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00518414
First Posted: August 20, 2007
Last Update Posted: September 28, 2015
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.
Information provided by (Responsible Party):
Mead Johnson Nutrition
  Purpose
Infants will be fed infant formula and blood drawn to measure fatty acid levels in the blood.

Condition Intervention
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 Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Mead Johnson Nutrition:

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

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

Enrollment: 136
Study Start Date: April 2007
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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 Submitted: August 17, 2007
First Posted: August 20, 2007
Last Update Posted: September 28, 2015
Last Verified: September 2015

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