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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-12-31

Brief Summary

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

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Detailed Description

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Conditions

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Cow's Milk Allergy Intolerance to Extensively Hydrolyzed Formulas Intolerance to Breast Milk

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Arm 1 - AA Formula with DHA and ARA

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

Group Type OTHER

Amino Acid-based Formula with high DHA and ARA

Intervention Type OTHER

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

Group Type OTHER

Amino Acid-based Formula with lower DHA and ARA

Intervention Type OTHER

Interventions

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Amino Acid-based Formula with high DHA and ARA

Intervention Type OTHER

Amino Acid-based Formula with lower DHA and ARA

Intervention Type OTHER

Eligibility Criteria

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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

Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No