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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 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:
NCT01112904
First received: April 27, 2010
Last updated: July 2, 2014
Last verified: July 2014
  Purpose

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.


Condition
Docosahexanoic Acid (DHA) Status

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: n-3 Fatty Acids and Early Child Nutrition: 5-Year-Olds Follow-Up Study

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • maternal DHA status in gestation [ Time Frame: 16 & 36 weeks gestation ] [ Designated as safety issue: No ]
    red blood cell DHA biochemistries


Secondary Outcome Measures:
  • plasma lutein and Red blood cell DHA [ Time Frame: 5 years 8 months to 6 years ] [ Designated as safety issue: No ]
    plasma lutein and red blood cell DHA biochemistries


Other Outcome Measures:
  • cognitive development with standardized developmental tests [ Time Frame: 5 years 8 months to 6 years ] [ Designated as safety issue: No ]
    Assessment with the Kaufman Developmental Assessment Battery


Biospecimen Retention:   Samples With DNA

Plasma and blood cells


Estimated Enrollment: 209
Study Start Date: February 2010
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   19 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01112904

Contacts
Contact: Julie S Matheson, B.Sc 604-875-2345 ext 4896 jmatheson@cfri.ca

Locations
Canada, British Columbia
Child & Family Research Institute, Nutrition and Metabolism Research Program Recruiting
Vancouver, British Columbia, Canada, V5Z4H4
Contact: Julie S Matheson, B.Sc.    604-875-2435 ext 4896    jmatheson@cfri.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: NCT01112904     History of Changes
Other Study ID Numbers: H09-01633
Study First Received: April 27, 2010
Last Updated: July 2, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
essential fatty acids
DHA status
preschool children
gestation

ClinicalTrials.gov processed this record on October 01, 2014