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

This study has been completed.
Sponsor:
Collaborator:
University of Alberta
Information provided by:
Mead Johnson Nutrition
ClinicalTrials.gov Identifier:
NCT01058187
First received: January 26, 2010
Last updated: March 10, 2014
Last verified: March 2014
  Purpose

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
Levels of Fatty Acids in the Blood Cells of Infants

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Mead Johnson Nutrition:

Estimated Enrollment: 86
Study Start Date: February 2010
Study Completion Date: July 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   up to 25 Days
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Deolinda Scalabrin, M.D., Mead Johnson Nutrition
ClinicalTrials.gov Identifier: NCT01058187     History of Changes
Other Study ID Numbers: 6000
Study First Received: January 26, 2010
Last Updated: March 10, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 01, 2014