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

Resource links provided by NLM:


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
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 April 22, 2014