NCT01112930

Brief Summary

In humans, docosahexanoic acid (DHA) is concentrated in brain. After birth, DHA is obtained from breast milk or the child's diet. The investigators are studying whether DHA intakes in young children are adequate to support brain development. This is a cross-sectional study of children 5-6 years-old.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
187

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2010

Longer than P75 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 29, 2010

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

April 15, 2015

Status Verified

April 1, 2015

Enrollment Period

4.8 years

First QC Date

April 27, 2010

Last Update Submit

April 14, 2015

Conditions

Breastfeeding

Keywords

essential fatty acidsDHApreschool childrendocosahexanoic acid (DHA)

Outcome Measures

Primary Outcomes (1)

  • plasma lutein and red blood cell DHA

    plasma lutein and red blood cell DHA biochemistries

    5 years 8 months to 6 years

Secondary Outcomes (1)

  • cognitive development with standardized developmental tests

    5 years 8 months to 6 years

Eligibility Criteria

Age5 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

This is a cross-sectional study of children 5-6 years-old.

You may qualify if:

  • comfortable to speak and read in English
  • parent or primary caregiver of a healthy child that is 5-6 years of age.

You may not qualify if:

  • not capable/comfortable with reading, speaking and writing the English language.
  • not the parent or primary caregiver or legal guardian of a 5-6 year-old child.
  • the child that is not in good health or has severe food allergies or a metabolic, neurological, genetic, or immune disorder that influences the child's food choices will not be able to participate in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Child & Family Research Institute, Nutrition and Metabolism Research Program

Vancouver, British Columbia, V5Z4H4, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma and blood cells

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Sheila M. Innis, Dr.

    University of British Columbia

    PRINCIPAL INVESTIGATOR

  • Tim Oberlander, MD

    University of British Columbia

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2010

First Posted

April 29, 2010

Study Start

February 1, 2010

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

April 15, 2015

Record last verified: 2015-04

Locations

CA(1)