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

August 31, 2011 updated by: Mead Johnson Nutrition
The clinical trial will provide a milk-based drink with constant amounts of nutrients but differing amount of Docosahexaenoic Acid (DHA).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 3 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
Growth
Adverse Events
Determination of nutrient status, including iron and vitamin D status

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mead Johnson Nutrition

Investigators

  • Principal Investigator: Susan Carlson, Ph.D., University of Kansas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

July 30, 2010

First Submitted That Met QC Criteria

August 2, 2010

First Posted (Estimate)

August 3, 2010

Study Record Updates

Last Update Posted (Estimate)

September 2, 2011

Last Update Submitted That Met QC Criteria

August 31, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Other Study ID Numbers

  • 3375-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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