NCT01174134

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

July 30, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 3, 2010

Completed
Last Updated

September 2, 2011

Status Verified

August 1, 2011

Enrollment Period

10 months

First QC Date

July 30, 2010

Last Update Submit

August 31, 2011

Conditions

Levels of DHA in the Blood

Outcome Measures

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 (3)

  • Growth

  • Determination of nutrient status, including iron and vitamin D status

  • Adverse Events

Study Arms (3)

Milk-based beverage w/out DHA

PLACEBO COMPARATOR
Other: Nutritional beverage

Milk-based beverage with DHA

EXPERIMENTAL
Other: Nutritional beverage

Milk-based beverage containing DHA at a higher level

EXPERIMENTAL
Other: Nutritional beverage

Interventions

Nutritional beverageOTHER
Milk-based beverage containing DHA at a higher levelMilk-based beverage w/out DHAMilk-based beverage with DHA

Eligibility Criteria

Age18 Months - 36 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas

Kansas City, Kansas, 66160, United States

Location

Study Officials

  • Susan Carlson, Ph.D.

    University of Kansas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 30, 2010

First Posted

August 3, 2010

Study Start

July 1, 2006

Primary Completion

May 1, 2007

Last Updated

September 2, 2011

Record last verified: 2011-08

Locations

US(1)