Essential Fatty Acid (EFA) Nutrition 5-Year-Olds X Section

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01112930
Recruitment Status : Completed
First Posted : April 29, 2010
Last Update Posted : April 15, 2015
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
University of British Columbia

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.

Condition or disease

Detailed Description:

This research involves recruitment of a cross-sectional cohort of children 5 years of age and their mothers. The purpose is to assess the relationship between the child's diet, DHA status and neural, cognitive and behavioral development. Hypotheses: 1. Children with low DHA status will be at increased risk for poor scores on tests of development. 2. Family food practices will be major determinant of DHA intake of preschool children in our population. 3. Genetic variation in fatty acid metabolism will influence blood fatty acids in preschool children.

Objectives: 1. To determine if low DHA status among children 5-6 years-of-age is associated with low scores on tests of development; 2. To identify the dietary patterns that place children at risk for poor DHA status, 3. To show genetic variation also alters blood fatty acids in children.

This research will recruit a cohort of 5-6year-old children (n= 200). Subjects will attend our nutrition lab at the Child and Family Research Institute where the child will complete play-like developmental assessments. Measurement of blood pressure, heart rate, height and weight will be completed and blood samples will be collected to measure DHA status and polymorphisms (SNP) in genes of fatty acid metabolism. The parent will be asked to provide information on the child' diet and health. Baseline characteristics for the subjects will be summarized using descriptive statistics. Logistic regression will be used to assess the relationship of DHA status to cognitive development with multi-variable-adjusted odds ratios (ORs) of a negative outcome and corresponding 95% confidence interval (CI). Regressions will also be run with the outcomes in continuous form to assess the changes in scores associated with increments of child DHA status. For all multivariate regression models, potential confounders will be screened in stepwise fashion, and any covariate with a regression coefficient P-value < 0.05 (two-sided) will be retained. Variables will include gender, birth weight, gestation length, maternal intelligence quotient (IQ), ethnicity, breast-feeding duration, birth order, and dichotomized variables of child health, eating behavior and martial status. Children will grouped in quintiles of blood DHA and descriptive statistics will be used to present intakes of total fat, individual fatty acids. ANOVA will be used to determine if genetic variables in Fetal Akinesia Deformation Sequence (FADS) influence blood DHA.

Study Type : Observational
Actual Enrollment : 187 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: n-3 Fatty Acids and Early Child Nutrition: 5-Year-Olds X-Section Study
Study Start Date : February 2010
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Primary Outcome Measures :
  1. plasma lutein and red blood cell DHA [ Time Frame: 5 years 8 months to 6 years ]
    plasma lutein and red blood cell DHA biochemistries

Secondary Outcome Measures :
  1. cognitive development with standardized developmental tests [ Time Frame: 5 years 8 months to 6 years ]
    Assessment with the Kaufman Developmental Assessment Battery

Biospecimen Retention:   Samples With DNA
Plasma and blood cells

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
This is a cross-sectional study of children 5-6 years-old.

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01112930

Canada, British Columbia
Child & Family Research Institute, Nutrition and Metabolism Research Program
Vancouver, British Columbia, Canada, V5Z4H4
Sponsors and Collaborators
University of British Columbia
Canadian Institutes of Health Research (CIHR)
Principal Investigator: Sheila M. Innis, Dr. University of British Columbia
Study Director: Tim Oberlander, MD University of British Columbia

Responsible Party: University of British Columbia Identifier: NCT01112930     History of Changes
Other Study ID Numbers: H09-02921
First Posted: April 29, 2010    Key Record Dates
Last Update Posted: April 15, 2015
Last Verified: April 2015

Keywords provided by University of British Columbia:
essential fatty acids
preschool children
docosahexanoic acid (DHA)