The Evaluation of Cow Milk-Based Formulas

Not Applicable

Completed

• Conditions: Term Infants
• Interventions: 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

• Registration Number: NCT00518414
• Lead Sponsor: Mead Johnson Nutrition

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2007-08-17
• Study First Submitted QC: 2007-08-17
• Study First Posted: 2007-08-20
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-24
• Last Update Posted: 2015-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

Inclusion Criteria

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

Exclusion Criteria

• Breast fed infants
• Infants with formula intolerance

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Marketed infant formula with DHA and ARA	Marketed infant formula with DHA and ARA	Marketed milk-based infant formula containing docosahexaenoic acid (DHA) and arachidonic acid (ARA)
Milk-based infant formula with DHA and ARA	Milk-based infant formula with DHA and ARA	Experimental milk-based infant formula containing docosahexaenoic acid (DHA) and arachidonic acid (ARA)
Milk-based formula with DHA, ARA, prebiotics	Milk-based formula with DHA, ARA, prebiotics	Experimental milk-based infant formula containing docosahexaenoic acid (DHA) and arachidonic acid (ARA) and prebiotic blend

Primary Outcome Measures

Name	Time	Method
Red Blood Cell (RBC) ARA and DHA	120 Days of age

Secondary Outcome Measures

Name	Time	Method
Phospholipid fatty acids, tolerance	120 Days of age

Trial Locations

Locations (9)

Birmingham Pediatric Group; 🇺🇸 Birmingham, Alabama, United States

Southlake Pediatrics; 🇺🇸 Birmingham, Alabama, United States

Children's Medical Association; 🇺🇸 Tamarac, Florida, United States

Welborn Clinic; 🇺🇸 Evansville, Indiana, United States

DCOL Center for Clinical Research; 🇺🇸 Longview, Texas, United States

Holston Medical Group; 🇺🇸 Kingsport, Tennessee, United States

Northwood Pediatrics; 🇺🇸 The Woodlands, Texas, United States

The Center for Human Nutrition; 🇺🇸 Omaha, Nebraska, United States

Arkansas Pediatric Clinic; 🇺🇸 Little Rock, Arkansas, United States