Evaluation of Fatty Acid Levels and Growth in Infants Fed Amino Acid Based (AA) Formulas
Primary Purpose
Cow's Milk Allergy, Intolerance to Extensively Hydrolyzed Formulas, Intolerance to Breast Milk
Status
Withdrawn
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Amino Acid-based Formula with high DHA and ARA
Amino Acid-based Formula with lower DHA and ARA
Sponsored by
About this trial
This is an interventional diagnostic trial for Cow's Milk Allergy
Eligibility 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
Sites / Locations
- Great Ormand Street Hospital and Institute of Child Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Arm 1 - AA Formula with DHA and ARA
Arm 2 - AA Formula with alternative levels of DHA and ARA
Arm Description
Marketed AA formula with Docosahexanoic Acid (DHA) and Arachidonic Acid (ARA)
Outcomes
Primary Outcome Measures
Level of fatty acids in whole blood of infants
Secondary Outcome Measures
body weight
Occurrence of allergic manifestations
Occurrence of adverse events
Incidence of gas
Incidence of fussiness
Stool characteristics
Body length
Head Circumference
Full Information
NCT ID
NCT01470768
First Posted
October 26, 2011
Last Updated
March 20, 2012
Sponsor
Mead Johnson Nutrition
1. Study Identification
Unique Protocol Identification Number
NCT01470768
Brief Title
Evaluation of Fatty Acid Levels and Growth in Infants Fed Amino Acid Based (AA) Formulas
Official Title
Evaluation of Fatty Acid Levels and Growth in Infants Fed Amino Acid Based Formulas
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Withdrawn
Why Stopped
Sponsor cancelled study
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mead Johnson Nutrition
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This clinical trial will compare the amount of fatty acids in whole blood of babies fed one of two study formulas for 4 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cow's Milk Allergy, Intolerance to Extensively Hydrolyzed Formulas, Intolerance to Breast Milk
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1 - AA Formula with DHA and ARA
Arm Type
Other
Arm Description
Marketed AA formula with Docosahexanoic Acid (DHA) and Arachidonic Acid (ARA)
Arm Title
Arm 2 - AA Formula with alternative levels of DHA and ARA
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Amino Acid-based Formula with high DHA and ARA
Intervention Type
Other
Intervention Name(s)
Amino Acid-based Formula with lower DHA and ARA
Primary Outcome Measure Information:
Title
Level of fatty acids in whole blood of infants
Time Frame
4 months
Secondary Outcome Measure Information:
Title
body weight
Time Frame
4 months
Title
Occurrence of allergic manifestations
Time Frame
4 months
Title
Occurrence of adverse events
Time Frame
4 months
Title
Incidence of gas
Time Frame
4 months
Title
Incidence of fussiness
Time Frame
4 months
Title
Stool characteristics
Time Frame
4 months
Title
Body length
Time Frame
4 months
Title
Head Circumference
Time Frame
4 months
10. Eligibility
Sex
All
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nikhil Thapar, M.D.
Organizational Affiliation
UCL Institute of Child Health and Great Ormond Street Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Great Ormand Street Hospital and Institute of Child Health
City
London
State/Province
United Kingdon
ZIP/Postal Code
WC1N1EH
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
33006765
Citation
Amari S, Shahrook S, Namba F, Ota E, Mori R. Branched-chain amino acid supplementation for improving growth and development in term and preterm neonates. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD012273. doi: 10.1002/14651858.CD012273.pub2.
Results Reference
derived
Learn more about this trial
Evaluation of Fatty Acid Levels and Growth in Infants Fed Amino Acid Based (AA) Formulas
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