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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01470768
Other study ID # 6005
Secondary ID
Status Withdrawn
Phase N/A
First received October 26, 2011
Last updated March 20, 2012
Start date January 2012
Est. completion date December 2013

Study information

Verified date March 2012
Source Mead Johnson Nutrition
Contact n/a
Is FDA regulated No
Health authority United Kingdom: National Research Ethics Service (NRES) Committee London - Riverside
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 2013
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Both
Age group N/A to 6 Months
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Other:
Amino Acid-based Formula with high DHA and ARA

Amino Acid-based Formula with lower DHA and ARA


Locations

Country Name City State
United Kingdom Great Ormand Street Hospital and Institute of Child Health London United Kingdon

Sponsors (1)

Lead Sponsor Collaborator
Mead Johnson Nutrition

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Level of fatty acids in whole blood of infants 4 months No
Secondary body weight 4 months No
Secondary Occurrence of allergic manifestations 4 months No
Secondary Occurrence of adverse events 4 months No
Secondary Incidence of gas 4 months No
Secondary Incidence of fussiness 4 months No
Secondary Stool characteristics 4 months No
Secondary Body length 4 months No
Secondary Head Circumference 4 months No
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