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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This study has been withdrawn prior to enrollment.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:
Information provided by (Responsible Party):
Mead Johnson Nutrition
ClinicalTrials.gov Identifier:
NCT01470768
First received: October 26, 2011
Last updated: March 20, 2012
Last verified: March 2012
History of Changes
  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: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: Allergy
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • body weight [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Occurrence of allergic manifestations [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Occurrence of adverse events [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Incidence of gas [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Incidence of fussiness [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Stool characteristics [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Body length [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Head Circumference [ Time Frame: 4 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   up to 6 Months
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Mead Johnson Nutrition
ClinicalTrials.gov Identifier: NCT01470768     History of Changes
Other Study ID Numbers: 6005
Study First Received: October 26, 2011
Last Updated: March 20, 2012
Health Authority: United Kingdom: National Research Ethics Service (NRES) Committee London - Riverside

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

ClinicalTrials.gov processed this record on May 16, 2013