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

Not Applicable

Withdrawn

• Conditions: Cow's Milk Allergy; Intolerance to Extensively Hydrolyzed Formulas; Intolerance to Breast Milk
• Interventions: Other: Amino Acid-based Formula with high DHA and ARA; Other: Amino Acid-based Formula with lower DHA and ARA

• Registration Number: NCT01470768
• Lead Sponsor: Mead Johnson Nutrition

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-10-26
• Study First Submitted QC: 2011-11-10
• Study First Posted: 2011-11-11
• Study Start: 2012-01
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-20
• Last Update Posted: 2012-03-22
• Primary Completion: 2013-12
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1 - AA Formula with DHA and ARA	Amino Acid-based Formula with high DHA and ARA	Marketed AA formula with Docosahexanoic Acid (DHA) and Arachidonic Acid (ARA)
Arm 2 - AA Formula with alternative levels of DHA and ARA	Amino Acid-based Formula with lower DHA and ARA	-

Primary Outcome Measures

Name	Time	Method
Level of fatty acids in whole blood of infants	4 months

Secondary Outcome Measures

Name	Time	Method
body weight	4 months
Occurrence of allergic manifestations	4 months
Occurrence of adverse events	4 months
Incidence of gas	4 months
Incidence of fussiness	4 months
Stool characteristics	4 months
Body length	4 months
Head Circumference	4 months

Trial Locations

Locations (1)

Great Ormand Street Hospital and Institute of Child Health; 🇬🇧 London, United Kingdon, United Kingdom