Essential Fatty Acid (EFA) Nutrition 5-Year-Olds Follow-Up Study

n-3 Fatty Acids and Early Child Nutrition: 5-Year-Olds Follow-Up Study

Docosahexanoic acid (DHA) is concentrated in the human brain. Before birth, DHA is transferred across the placenta, but transfer depends on maternal DHA intake. After birth, DHA is provided by breast milk or the child's diet. This study addresses whether DHA intakes are adequate to support human brain development.

In a previous study "N-3 Fatty Acid Requirements for Human Development" (C03-0242), pregnant women were randomly assigned to 400 mg/day DHA or placebo from 16 weeks of gestation until infant delivery. Blood DHA in gestation, and infant development to 18 months were assessed. This follow-up study will assess if maternal DHA in gestation has long-term influence on child development when assessed at 5 years and the impact of the child's own diet.

Study Overview

• Status: Completed
• Conditions: Docosahexanoic Acid (DHA) Status

Detailed Description

This research is a prospective follow-up on an existing cohort of women and their children to determine whether dietary intakes of docosahexaenoic acid (DHA) during pregnancy have effects lasting into early childhood. The purpose of this study is to assess the relationship between maternal DHA status in gestation, which is known, and the child 's own diet and relevant genetic variables on the child's neural, cognitive and behavioral development. Hypotheses: 1. maternal DHA status in gestation has a lasting effect on infant development evident when assessed in early childhood 2. Children with low DHA status will be at increased risk for poor scores on tests of development. 3. Genetic variation in fatty acid metabolism will influence blood fatty acids in preschool children.

Objectives: 1. To determine if low maternal DHA status in gestation is related to child development at 5 years of age; 2. To determine the DHA status of children 5 years-of-age in relation to scores on tests of development; 3. To identify the dietary patterns that place children at risk for poor DHA status; 4. To assess if genetic variation in fatty acid metabolism alters blood lipid fatty acids in children This research is a prospective follow-up of 209 children that were last assessed at age 18 months and for whom maternal DHA status in gestation is known. The children with their parents are invited to 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, other relevant nutrient that impact development and genetic variables relevant to fatty acids. The parent will 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 DHA status and descriptive statistics will be used to present intakes of total fat, individual fatty acids. ANOVA will be used to determine if genetic variables influence blood DHA status.

• Study Type: Observational
• Enrollment (Actual): 98

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z4H4
      • Child & Family Research Institute, Nutrition and Metabolism Research Program

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Mothers who participated in study (REB # C03-0242 and C&W W03-0084) and who have already provided written consent for re-contact to participate with their 5 year old child will participate in this follow-up study

Description

Inclusion Criteria:

• Mothers who participated in study (REB # C03-0242 and C&W W03-0084)
• who have already provided written consent for re-contact to participate with their 5 year old child.

Exclusion Criteria:

• Mothers who did not participate in the previous study "N-3 fatty acid requirements for human development"
• Mothers who have not provided written consent for re-contact.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
maternal DHA status in gestation	red blood cell DHA biochemistries	16 & 36 weeks gestation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
plasma lutein and Red blood cell DHA	plasma lutein and red blood cell DHA biochemistries	5 years 8 months to 6 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
cognitive development with standardized developmental tests	Assessment with the Kaufman Developmental Assessment Battery	5 years 8 months to 6 years

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: Canadian Institutes of Health Research (CIHR)
• Investigators: Study Director: Tim Oberlander, MD, University of British Columbia

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: April 27, 2010
• First Submitted That Met QC Criteria: April 27, 2010
• First Posted (Estimate): April 29, 2010

Study Record Updates

• Last Update Posted (Estimate): April 15, 2015
• Last Update Submitted That Met QC Criteria: April 14, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: preschool children; essential fatty acids; DHA status; gestation
• Other Study ID Numbers: H09-01633