The Evaluation of Cow Milk-Based Formulas
1 other identifier
interventional
136
1 country
9
Brief Summary
Infants will be fed infant formula and blood drawn to measure fatty acid levels in the blood.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2007
Shorter than P25 for not_applicable
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 17, 2007
CompletedFirst Posted
Study publicly available on registry
August 20, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2008
CompletedSeptember 28, 2015
September 1, 2015
9 months
August 17, 2007
September 24, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Red Blood Cell (RBC) ARA and DHA
120 Days of age
Secondary Outcomes (1)
Phospholipid fatty acids, tolerance
120 Days of age
Study Arms (3)
Marketed infant formula with DHA and ARA
ACTIVE COMPARATORMarketed milk-based infant formula containing docosahexaenoic acid (DHA) and arachidonic acid (ARA)
Milk-based infant formula with DHA and ARA
EXPERIMENTALExperimental milk-based infant formula containing docosahexaenoic acid (DHA) and arachidonic acid (ARA)
Milk-based formula with DHA, ARA, prebiotics
EXPERIMENTALExperimental milk-based infant formula containing docosahexaenoic acid (DHA) and arachidonic acid (ARA) and prebiotic blend
Interventions
Eligibility Criteria
You may qualify if:
- Healthy, term infant
- to 18 days of age
You may not qualify if:
- Breast fed infants
- Infants with formula intolerance
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Birmingham Pediatric Group
Birmingham, Alabama, 35205, United States
Southlake Pediatrics
Birmingham, Alabama, 35244, United States
Arkansas Pediatric Clinic
Little Rock, Arkansas, 72205, United States
Children's Medical Association
Tamarac, Florida, 33321, United States
Welborn Clinic
Evansville, Indiana, 47714, United States
The Center for Human Nutrition
Omaha, Nebraska, 68105, United States
Holston Medical Group
Kingsport, Tennessee, 37660, United States
DCOL Center for Clinical Research
Longview, Texas, 75605, United States
Northwood Pediatrics
The Woodlands, Texas, 77380, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Carol L Berseth, M.D.
Mead Johnson Nutritionals
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 17, 2007
First Posted
August 20, 2007
Study Start
April 1, 2007
Primary Completion
January 1, 2008
Study Completion
January 1, 2008
Last Updated
September 28, 2015
Record last verified: 2015-09