Assessment of Arachidonic Acid Supplementation in Infant Formula on the Immune Response of Infants
NCT ID: NCT02092857
Last Updated: 2014-04-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
89 participants
INTERVENTIONAL
2009-12-31
2014-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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34 mg/100 kcal arachidonic acid
10 weeks exclusive feeding with infant formula containing 34 mg/100 kcal of arachidonic acid
Arachidonic acid (34 mg/100 kcal)
25 mg/100 kcal arachidonic acid
10 weeks exclusive feeding with infant formula containing 25 mg/100 kcal of arachidonic acid
Arachidonic acid (25 mg/100 kcal )
Infant formula without arachidonic acid
10 weeks exclusive infant formula feeding (without supplemental arachidonic acid).
Placebo
10 weeks exclusive infant formula feeding (without supplemental arachidonic acid).
Interventions
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Arachidonic acid (25 mg/100 kcal )
Arachidonic acid (34 mg/100 kcal)
Placebo
10 weeks exclusive infant formula feeding (without supplemental arachidonic acid).
Eligibility Criteria
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Inclusion Criteria
* birth weight, length and head circumference between the 5th and 95th percentile for gestational age (according to the National Center for Health Statistics growth charts)
* receiving \>80% for their intake by mouth from commercial infant formula
* low-risk for allergy based on a negative family history.
Exclusion Criteria
* red cell or plasma transfusions
* IV lipid emulsions prior to study entry
* major congenital malformations
* systemic or congenital infection
* significant neonatal morbidity
* maternal autoimmune disorders
* acute illness precluding oral feedings or conditions requiring feedings other than standard formula
14 Days
21 Days
ALL
Yes
Sponsors
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Mead Johnson Nutrition
INDUSTRY
University of Alberta
OTHER
Responsible Party
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Principal Investigators
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Michael T Clandinin, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Alberta
Locations
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University of Alberta Hospital
Edmonton, Alberta, Canada
Countries
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Other Identifiers
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230831
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
Pro00005583
Identifier Type: -
Identifier Source: org_study_id
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