The Evaluation of Cow Milk-Based Formulas

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mead Johnson Nutrition
ClinicalTrials.gov Identifier:
NCT00518414
First received: August 17, 2007
Last updated: September 24, 2015
Last verified: September 2015
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Phospholipid fatty acids, tolerance [ Time Frame: 120 Days of age ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   up to 18 Days
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: August 17, 2007
Last Updated: September 24, 2015
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 26, 2016