Essential Fatty Acid (EFA) Nutrition 5-Year-Olds X Section
|ClinicalTrials.gov Identifier: NCT01112930|
Recruitment Status : Completed
First Posted : April 29, 2010
Last Update Posted : April 15, 2015
|Condition or disease|
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|
|Official Title:||n-3 Fatty Acids and Early Child Nutrition: 5-Year-Olds X-Section Study|
|Study Start Date :||February 2010|
|Primary Completion Date :||November 2014|
|Study Completion Date :||November 2014|
- plasma lutein and red blood cell DHA [ Time Frame: 5 years 8 months to 6 years ]plasma lutein and red blood cell DHA biochemistries
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01112930
|Canada, British Columbia|
|Child & Family Research Institute, Nutrition and Metabolism Research Program|
|Vancouver, British Columbia, Canada, V5Z4H4|
|Principal Investigator:||Sheila M. Innis, Dr.||University of British Columbia|
|Study Director:||Tim Oberlander, MD||University of British Columbia|