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

NCT ID: NCT01174134

Last Updated: 2011-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Levels of DHA in the Blood

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Milk-based beverage w/out DHA

Group Type PLACEBO_COMPARATOR

Nutritional beverage

Intervention Type OTHER

Milk-based beverage with DHA

Group Type EXPERIMENTAL

Nutritional beverage

Intervention Type OTHER

Milk-based beverage containing DHA at a higher level

Group Type EXPERIMENTAL

Nutritional beverage

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nutritional beverage

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Months

Maximum Eligible Age

36 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mead Johnson Nutrition

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mead Johnson Nutrition

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Susan Carlson, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Kansas

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Kansas

Kansas City, Kansas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

3375-1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

An Evaluation of Omega-3 Fatty Acid
NCT03017651 COMPLETED PHASE1
Fish Oil and Muscle Function
NCT01308957 COMPLETED NA