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Assessment of Fatty Acids in Infants' Blood Cells When Consuming Infant Formula Containing Long-Chain Polyunsaturated Fatty Acids

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ClinicalTrials.gov Identifier: NCT01058187
Recruitment Status : Completed
First Posted : January 28, 2010
Last Update Posted : March 12, 2014
Sponsor:
Collaborator:
University of Alberta
Information provided by:
Mead Johnson Nutrition

Brief Summary:
To compare amounts of DHA, ARA, and other fatty acids in the blood cells of infants consuming infant formulas containing differing levels of fatty acids

Condition or disease
Levels of Fatty Acids in the Blood Cells of Infants

Study Type : Observational
Estimated Enrollment : 86 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Fatty Acids in Infants' Blood Cells When Consuming Infant Formula Containing Long-Chain Polyunsaturated Fatty Acids
Study Start Date : February 2010
Actual Primary Completion Date : May 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
Control
Marketed cow milk-based infant formula containing DHA and ARA
Investigational 1
Cow milk-based infant formula with differing level of ARA from Control formula
Investigational 2
Cow milk-based infant formula with a differing level of ARA from Control




Information from the National Library of Medicine

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Ages Eligible for Study:   up to 25 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Infants 12-25 days of age
Criteria

Inclusion Criteria:

  • Singleton birth
  • 12-25 days of age
  • Gestational age of 37-42 weeks
  • Solely formula fed for at least 24 hours prior to randomization
  • Birth weight 2500 g - 4000 g

Exclusion Criteria:

  • Serious concurrent illness or congenital malformation
  • Systemic or congenital infection
  • Immunocompromised
  • History of intolerance or allergy to cow milk
  • Maternal autoimmune disorder
  • Participation in another clinical study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01058187


Locations
Canada, Alberta
Alberta Institute for Human Nutrition, University of Alberta
Edmonton, Alberta, Canada, T6G2P5
Sponsors and Collaborators
Mead Johnson Nutrition
University of Alberta
Investigators
Principal Investigator: Tom Clandinin, Ph.D. University of Alberta

Responsible Party: Deolinda Scalabrin, M.D., Mead Johnson Nutrition
ClinicalTrials.gov Identifier: NCT01058187     History of Changes
Other Study ID Numbers: 6000
First Posted: January 28, 2010    Key Record Dates
Last Update Posted: March 12, 2014
Last Verified: March 2014