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临床试验/NCT01112930
NCT01112930已完成不适用

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

University of British Columbia1 个研究点 分布在 1 个国家目标入组 187 人开始时间: 2010年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
187
试验地点
1
主要终点
plasma lutein and red blood cell DHA

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
5 Years 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • comfortable to speak and read in English
  • parent or primary caregiver of a healthy child that is 5-6 years of age.

排除标准

  • 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.

结局指标

主要结局

plasma lutein and red blood cell DHA

时间窗: 5 years 8 months to 6 years

plasma lutein and red blood cell DHA biochemistries

次要结局

  • cognitive development with standardized developmental tests(5 years 8 months to 6 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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