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

Breastfeeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01112930
• Other study ID #: H09-02921
• Status: Completed
• Phase: N/A
• First received: April 27, 2010
• Last updated: April 14, 2015
• Start date: February 2010
• Est. completion date: November 2014

Study information

• Verified date: April 2015
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 187
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Years to 6 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Breastfeeding

Locations

Country	Name	City	State
Canada	Child & Family Research Institute, Nutrition and Metabolism Research Program	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	plasma lutein and red blood cell DHA	plasma lutein and red blood cell DHA biochemistries	5 years 8 months to 6 years	No
Secondary	cognitive development with standardized developmental tests	Assessment with the Kaufman Developmental Assessment Battery	5 years 8 months to 6 years	No