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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Withdrawn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
Mead Johnson Nutrition
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cow's Milk Allergy

Eligibility Criteria

undefined - 6 Months (Child)All SexesDoes not accept healthy volunteers

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

First Posted
October 26, 2011
Last Updated
March 20, 2012
Sponsor
Mead Johnson Nutrition
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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Withdrawn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

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

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