Essential Fatty Acid Nutrition For 1-2 Yr-Olds

Not Applicable

Completed

• Conditions: Infant Nutrition
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: LCPUFA Supplement

• Registration Number: NCT01263912
• Lead Sponsor: University of British Columbia

Brief Summary

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.

Detailed Description

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).

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2010-12-17
• Study First Submitted QC: 2010-12-20
• Study First Posted: 2010-12-21
• Primary Completion: 2015-08
• Study Completion: 2016-12
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-29
• Last Update Posted: 2017-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 133

Inclusion Criteria

Not provided

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Exclusion Criteria

• any infant that does not meet the inclusion criteria will not be included in this study.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A Placebo	Placebo	400 mg/day corn oil
LCPUFA Supplement	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).

Primary Outcome Measures

Name	Time	Method
Developmental test scores	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.

Secondary Outcome Measures

Name	Time	Method
Incidence and duration of illness	12 months (at baseline and age 18 and 24 months)	Parental reports of illness and duration
Growth (weight, kg)	12 months (at baseline and age 18 and 24 months)	Weight of at baseline, 18 and 24 months in relation to LCPUFA
Growth (height)	12 months (at baseline and age 18 and 24 months)	Height at baseline, 18 and 24 months in relation to LCPUFA
Growth (BMI, kg/m2)	12 months (at baseline and age 18 and 24 months)	BMI at baseline, 18 and 24 months in relation to LCPUFA
Heart rate and heart rate variability	12 months (at baseline and 24 months of age)	Heart rate and heart rate variability in relation to LCPUFA status
Genetic variation in fatty acid desaturases	12 months (at 24 months of age)	Genetic variation in fatty acid desaturases in relation to LCPUFA status
Hemoglobin (g/dL)	12 months (at baseline and 24 months of age)	Hemoglobin concentration in relation to diet
Folate (nmol/L)	12 months (at baseline and 24 months of age)	Serum folate in relation to child diet
Growth (waist circumference, cm)	12 months (at baseline and age 18 and 24 months)	Waist circumference at baseline, 18 and 24 months in relation to LCPUFA
Plasma and Red Blood Cell fatty acids (% total fatty acids)	12 months (at 24 months of age)	Plasma and red blood cell fatty acids levels in relation to dietary LCPUFA intake
Vitamin B12 (pmol/L)	12 months (at baseline and 24 months of age)	Serum vitamin B12 in relation to child diet
Supplements and supplemented foods	12 months (at baseline and age 18 and 24 months)	Use of nutrient supplements and supplemented foods and child nutrient status.
Ferritin (ng/ml)	12 months (at baseline and 24 months of age)	Serum ferritin in relation to child diet
Choline metabolites (umol/L)	12 months (at baseline and 24 months of age)	Plasma free choline, betaine, and dimethylglycine in relation to child diet
Vitamin D (nmol/L)	12 months (at baseline and 24 months of age)	Serum vitamin D in relation to child diet
Systolic and diastolic blood pressure (mmHg)	12 months (at baseline and 24 months of age)	In clinic systolic and diastolic blood pressure in relation to LCPUFA status

Trial Locations

Locations (1)

BC Children's Hospital Research Institute, University of British Columbia; 🇨🇦 Vancouver, British Columbia, Canada