Essential Fatty Acid Nutrition in Infants 1 to 2 Years-of-Age
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 133
- 试验地点
- 2
- 主要终点
- Developmental test scores
研究概览
简要总结
This is a prospective longitudinal study that will involve 200 infants enrolled at 12-13 months of age. The study will use a classic nutrition design to assess if infants' feeding practices in Canada place infants 1-2 years of age at risk for low long chain polyunsaturated fatty acid (LCPUFA), nutrients known to influence growth, and brain and immune system development. On enrollment, infants will be assigned at random to a nutrition supplement providing omega 6 and omega 3 LCPUFA or a PUFA placebo.
详细描述
The objectives are to1. determine the change in dietary fat and PUFA intakes, change in biochemical measures of fatty acid status prospectively from enrollment to 24 months-of-age and 2. to use a nutritional intervention with LCPUFA to address if limiting status of these nutrients impacts growth and development to 24 months-of-age. Primary Endpoints are distributions of developmental tests scores, growth quality and parental reports of child illness. The Bayley Mental and Motor Scales (BSID-III), Peabody Picture Test, Beery Buktenica Developmental Test, Auditory Continuous Performance Test and Test of Attention and Distractibility are used. Growth is assessed as height, weight, and adipose tissue mass and distribution. Child illness is reported by the parent. Secondary endpoints are physiologic measures of blood pressure, heart rate and heart rate variability, and the genetic variables in fatty acid metabolism on fatty acid status and outcome. Blood is collected at enrolment and at 24 months-of-age. Lipids and fatty acids are assessed on plasma and blood cells. Routine, potentially confounding nutrients including iron, vitamin D, choline, folate and B12 are assessed. DNA is extracted from blood cells for genotyping. Dietary intake is assessed using a food frequency questionnaire (FFQ), 3 day food diaries and 24 hour recalls. A parent report illness dairy and questionnaire modified from the International Study of Asthma and Allergies in Childhood is used to assess illness incidence and duration. Descriptive statistics will be used to present subject characteristics, dietary intakes, growth and physiological measures and test results of total fat. Logistic regression, with multivariable-adjusted odds ratios (ORs) of a negative outcome and corresponding 95% CI will be sued to assess the effect of LCPUFA status on development, growth and health outcomes. For all multivariate 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. Performance on tests will be compared as LCPUFA status in the lowest quintile compared to highest quintile of outcome (i.e. the two ends of the distribution differ in LCPUFA status).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Months 至 13 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •any infant that does not meet the inclusion criteria will not be included in this study.
研究组 & 干预措施
LCPUFA Supplement
DHA/ARA supplement providing 200 mg/day docosahexaenoic acid (DHA) from DHASCO®-S oil and 200 mg/day arachidonic acid (ARA) from ARASCO® oil (DSM Nutritional Products).
干预措施: LCPUFA Supplement (Dietary Supplement)
A Placebo
400 mg/day corn oil
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Developmental test scores
时间窗: 12 months (at 24 months of age)
Bayley Scales of Infant and Toddler Development 3rd Edition and Beery-Buktenica Developmental Test of Visual -Motor Integration (5th Ed) composite scores at 24 months in relation to LCPUFA supplement group.
次要结局
- Growth (weight, kg)(12 months (at baseline and age 18 and 24 months))
- Growth (height)(12 months (at baseline and age 18 and 24 months))
- Growth (BMI, kg/m2)(12 months (at baseline and age 18 and 24 months))
- Incidence and duration of illness(12 months (at baseline and age 18 and 24 months))
- Heart rate and heart rate variability(12 months (at baseline and 24 months of age))
- Genetic variation in fatty acid desaturases(12 months (at 24 months of age))
- Hemoglobin (g/dL)(12 months (at baseline and 24 months of age))
- Folate (nmol/L)(12 months (at baseline and 24 months of age))
- Growth (waist circumference, cm)(12 months (at baseline and age 18 and 24 months))
- Plasma and Red Blood Cell fatty acids (% total fatty acids)(12 months (at 24 months of age))
- Vitamin B12 (pmol/L)(12 months (at baseline and 24 months of age))
- Supplements and supplemented foods(12 months (at baseline and age 18 and 24 months))
- Ferritin (ng/ml)(12 months (at baseline and 24 months of age))
- Choline metabolites (umol/L)(12 months (at baseline and 24 months of age))
- Vitamin D (nmol/L)(12 months (at baseline and 24 months of age))
- Systolic and diastolic blood pressure (mmHg)(12 months (at baseline and 24 months of age))
研究者
Angela Devlin
Principle Investigator
University of British Columbia