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

This study is currently recruiting participants.
Verified January 2013 by University of British Columbia
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01112930
First received: April 27, 2010
Last updated: January 3, 2013
Last verified: January 2013
  Purpose

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
Breastfeeding

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: n-3 Fatty Acids and Early Child Nutrition: 5-YR-Olds X-Section Study

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Biospecimen Retention:   Samples With DNA

Plasma and blood cells


Estimated Enrollment: 209
Study Start Date: February 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
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% 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 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 FADS influence blood DHA.

  Eligibility

Ages Eligible for Study:   5 Years to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01112930

Contacts
Contact: Sheila M. Innis, Dr. 604-875-2431 sinnis@interchange.ubc.ca

Locations
Canada, British Columbia
Child & Family Research Institute, Nutrition and Metabolism Research Program Recruiting
Vancouver, British Columbia, Canada, V5Z4H4
Contact: Sheila M. Innis, Dr.    604-875-2431    sinnis@interchange.ubc.ca   
Sponsors and Collaborators
University of British Columbia
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Sheila M. Innis, Dr. University of British Columbia
Study Director: Tim Oberlander, MD University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01112930     History of Changes
Other Study ID Numbers: H09-02921
Study First Received: April 27, 2010
Last Updated: January 3, 2013
Health Authority: Canada: Health Canada

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

ClinicalTrials.gov processed this record on April 17, 2014