Evaluation of Fatty Acid Levels and Growth in Infants Fed Amino Acid Based (AA) Formulas

Mead Johnson Nutrition

Status: Withdrawn

Conditions: Cow's Milk Allergy; Intolerance to Breast Milk; Intolerance to Extensively Hydrolyzed Formulas

Treatments: Other: Amino Acid-based Formula with high DHA and ARA; Other: Amino Acid-based Formula with lower DHA and ARA

Study type: Interventional

Funder types: Industry

Identifiers

NCT01470768

6005

Details and patient eligibility

About

This clinical trial will compare the amount of fatty acids in whole blood of babies fed one of two study formulas for 4 months.

Sex: All

Ages: Under 6 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 0 to 6 months of age inclusive
• Born at ≥ 37 weeks gestation
• Birth weight of 2500 g (5 lb 8 oz) or more
• Infants suspected to be cow's milk allergic and who do not tolerate extensively hydrolyzed formula OR infants intolerant to breast milk
• Infants with symptoms suggestive of cow's milk allergy
• Signed Informed Consent

Exclusion criteria

• Infants who for whatever reasons were not discharged home as per routine
• Infants with metabolic illness requiring a special formula
• Infants fed with nasogastric tube

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups

Arm 1 - AA Formula with DHA and ARA

Other group

Description:

Marketed AA formula with Docosahexanoic Acid (DHA) and Arachidonic Acid (ARA)

Treatment:

Other: Amino Acid-based Formula with high DHA and ARA

Arm 2 - AA Formula with alternative levels of DHA and ARA

Other group

Treatment:

Other: Amino Acid-based Formula with lower DHA and ARA