Skip to main content
OpenTrials
Completed

NCT Number: NCT01112930

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

5 year–6 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Child & Family Research Institute, Nutrition and Metabolism Research Program

Vancouver, British Columbia, V5Z4H4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  1. cognitive development with standardized developmental tests

    Time frame: 5 years 8 months to 6 years

    Assessment with the Kaufman Developmental Assessment Battery

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

n-3 Fatty Acids and Early Child Nutrition: 5-Year-Olds X-Section Study

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Apr 29, 2010
Registry last updated
Apr 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.