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

This study has been withdrawn prior to enrollment.
(Sponsor cancelled study)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01470768
First Posted: November 11, 2011
Last Update Posted: March 22, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mead Johnson Nutrition
  Purpose
This clinical trial will compare the amount of fatty acids in whole blood of babies fed one of two study formulas for 4 months.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Evaluation of Fatty Acid Levels and Growth in Infants Fed Amino Acid Based Formulas

Resource links provided by NLM:


Further study details as provided by Mead Johnson Nutrition:

Primary Outcome Measures:
  • Level of fatty acids in whole blood of infants [ Time Frame: 4 months ]

Secondary Outcome Measures:
  • body weight [ Time Frame: 4 months ]
  • Occurrence of allergic manifestations [ Time Frame: 4 months ]
  • Occurrence of adverse events [ Time Frame: 4 months ]
  • Incidence of gas [ Time Frame: 4 months ]
  • Incidence of fussiness [ Time Frame: 4 months ]
  • Stool characteristics [ Time Frame: 4 months ]
  • Body length [ Time Frame: 4 months ]
  • Head Circumference [ Time Frame: 4 months ]

Enrollment: 0
Study Start Date: January 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Arm 2 - AA Formula with alternative levels of DHA and ARA Other: Amino Acid-based Formula with lower DHA and ARA

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01470768


Locations
United Kingdom
Great Ormand Street Hospital and Institute of Child Health
London, United Kingdon, United Kingdom, WC1N1EH
Sponsors and Collaborators
Mead Johnson Nutrition
Investigators
Principal Investigator: Nikhil Thapar, M.D. UCL Institute of Child Health and Great Ormond Street Hospital
  More Information

Responsible Party: Mead Johnson Nutrition
ClinicalTrials.gov Identifier: NCT01470768     History of Changes
Other Study ID Numbers: 6005
First Submitted: October 26, 2011
First Posted: November 11, 2011
Last Update Posted: March 22, 2012
Last Verified: March 2012

Additional relevant MeSH terms:
Milk Hypersensitivity
Food Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases