Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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This study has been withdrawn prior to enrollment.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)
Information provided by (Responsible Party):
Mead Johnson Nutrition Identifier:
First received: October 26, 2011
Last updated: March 20, 2012
Last verified: March 2012

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:

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


Ages Eligible for Study:   up to 6 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01470768

United Kingdom
Great Ormand Street Hospital and Institute of Child Health
London, United Kingdon, United Kingdom, WC1N1EH
Sponsors and Collaborators
Mead Johnson Nutrition
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 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 processed this record on February 27, 2015