The Effects of Study Products Containing Varying Quantities of Docosahexaenoic Acid (DHA)

This study has been completed.
Sponsor:
Information provided by:
Mead Johnson Nutrition
ClinicalTrials.gov Identifier:
NCT01174134
First received: July 30, 2010
Last updated: August 31, 2011
Last verified: August 2011
  Purpose

The clinical trial will provide a milk-based drink with constant amounts of nutrients but differing amount of Docosahexaenoic Acid (DHA).


Condition Intervention
Levels of DHA in the Blood
Other: Nutritional beverage

Study Type: Interventional

Further study details as provided by Mead Johnson Nutrition:

Primary Outcome Measures:
  • Blood lipid levels of Docosahexaenoic Acid (DHA) at enrollment and after two months, assessment of usual DHA intake, and product acceptability and use

Secondary Outcome Measures:
  • Growth
  • Determination of nutrient status, including iron and vitamin D status
  • Adverse Events

Study Start Date: July 2006
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Milk-based beverage w/out DHA Other: Nutritional beverage
Experimental: Milk-based beverage with DHA Other: Nutritional beverage
Experimental: Milk-based beverage containing DHA at a higher level Other: Nutritional beverage

  Eligibility

Ages Eligible for Study:   18 Months to 36 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participant is 18 to 36 months of age
  • Participant's current weight and height within the 10th to 90th percentiles
  • Parent/caregiver reports that participant consumes milk or a milk-based beverage on a daily basis
  • Participant lives at home with parent(s) or other family member(s)
  • Signed informed consent and authorization obtained to use and or disclose Protected Health Information (PHI)

Exclusion Criteria:

  • Participant who is receiving any breast milk at time of randomization
  • Participant with an active infection.
  • Participant with a history of underlying disease, chronic disease, or congenital malformation which in the opinion of the Investigator is likely to interfere with the evaluation of the participant.
  • Known or suspected intolerance to cow's milk protein
  • Participant diagnosed with diabetes
  • Participant is from a multiple birth and the sibling(s) are still living
  • Participant with a sibling that has participated in this 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: NCT01174134

Locations
United States, Kansas
University of Kansas
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
Mead Johnson Nutrition
Investigators
Principal Investigator: Susan Carlson, Ph.D. University of Kansas
  More Information

No publications provided

Responsible Party: Carol Berseth, M.D., Mead Johnson Nutrition
ClinicalTrials.gov Identifier: NCT01174134     History of Changes
Other Study ID Numbers: 3375-1
Study First Received: July 30, 2010
Last Updated: August 31, 2011
Health Authority: United States: The University of Kansas Medical Center Human Subjects Committee (Institutional Review Board)

ClinicalTrials.gov processed this record on September 29, 2014