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

March 20, 2012 updated by: Mead Johnson Nutrition

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • United Kingdon
      • London, United Kingdon, United Kingdom, WC1N1EH
        • Great Ormand Street Hospital and Institute of Child Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 6 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Level of fatty acids in whole blood of infants
Time Frame: 4 months
4 months

Secondary Outcome Measures

Outcome Measure
Time Frame
body weight
Time Frame: 4 months
4 months
Occurrence of allergic manifestations
Time Frame: 4 months
4 months
Occurrence of adverse events
Time Frame: 4 months
4 months
Incidence of gas
Time Frame: 4 months
4 months
Incidence of fussiness
Time Frame: 4 months
4 months
Stool characteristics
Time Frame: 4 months
4 months
Body length
Time Frame: 4 months
4 months
Head Circumference
Time Frame: 4 months
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mead Johnson Nutrition

Investigators

  • Principal Investigator: Nikhil Thapar, M.D., UCL Institute of Child Health and Great Ormond Street Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Anticipated)

December 1, 2013

Study Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

October 26, 2011

First Submitted That Met QC Criteria

November 10, 2011

First Posted (Estimate)

November 11, 2011

Study Record Updates

Last Update Posted (Estimate)

March 22, 2012

Last Update Submitted That Met QC Criteria

March 20, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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