Assessment of Fatty Acids in Infants' Blood Cells When Consuming Infant Formula Containing Long-Chain Polyunsaturated Fatty Acids

Mead Johnson Nutrition

Status: Completed

Conditions: Levels of Fatty Acids in the Blood Cells of Infants

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01058187

6000

Details and patient eligibility

About

To compare amounts of DHA, ARA, and other fatty acids in the blood cells of infants consuming infant formulas containing differing levels of fatty acids

Enrollment: 86 estimated patients

Sex: All

Ages: 12 to 25 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Singleton birth
• 12-25 days of age
• Gestational age of 37-42 weeks
• Solely formula fed for at least 24 hours prior to randomization
• Birth weight 2500 g - 4000 g

Exclusion criteria

• Serious concurrent illness or congenital malformation
• Systemic or congenital infection
• Immunocompromised
• History of intolerance or allergy to cow milk
• Maternal autoimmune disorder
• Participation in another clinical study

Trial design

86 participants in 3 patient groups

Control

Description:

Marketed cow milk-based infant formula containing DHA and ARA

Investigational 1

Description:

Cow milk-based infant formula with differing level of ARA from Control formula

Investigational 2

Description:

Cow milk-based infant formula with a differing level of ARA from Control