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CompletedNCT01174134Updated Sep 2, 2011

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

An interventional study of Nutritional beverage in Levels of DHA in the Blood, sponsored by Mead Johnson Nutrition. Completed at 1 site in United States. Open to participants aged 18 Months to 36 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-09-02.

Sponsored by Mead Johnson Nutrition · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Ages
18 Months to 36 Months
Sex
All
01

Study summary

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

02

Conditions studied

  • Levels of DHA in the Blood
03

In context

Lead sponsor

Mead Johnson Nutrition is the lead sponsor of 56 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Months to 36 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable

Study arms

  • 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

Interventions

  • OtherNutritional beverage
06

What researchers measure

Primary outcomes

  1. Blood lipid levels of Docosahexaenoic Acid (DHA) at enrollment and after two months, assessment of usual DHA intake, and product acceptability and use

Secondary outcomes

  1. Growth

  2. Determination of nutrient status, including iron and vitamin D status

  3. Adverse Events

07

Study locations

1 site
  • University of Kansas
    Kansas City, Kansas 66160, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 2, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01174134
Lead sponsor
Mead Johnson Nutrition
First posted
Aug 3, 2010
Start date
Jul 2006
Primary completion
May 2007
Last update
Sep 2, 2011

Study contacts

Susan Carlson, Ph.D.
principal investigator · University of Kansas

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2011. You cannot join it, but the record below documents what was studied.

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Discussion

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