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Essential Fatty Acid Nutrition For 1-2 Yr-Olds

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ClinicalTrials.gov Identifier: NCT01263912
Recruitment Status : Completed
First Posted : December 21, 2010
Last Update Posted : December 1, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

December 17, 2010
December 21, 2010
December 1, 2017
December 2010
August 2015   (Final data collection date for primary outcome measure)
Developmental test scores [ Time Frame: 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.
  • Developmental test scores [ Time Frame: 12 months ]
    Distribution of developmental test scores at 18 and 24 months in relation to LCPUFA status
  • Growth and growth quality [ Time Frame: 12 months ]
    Distribution of growth measures at 18 and 24 months in relation to LCPUFA status
  • Incidence and duration of illness [ Time Frame: 12 months ]
    Parental reports of illness and duration
Complete list of historical versions of study NCT01263912 on ClinicalTrials.gov Archive Site
  • Plasma and Red Blood Cell fatty acids (% total fatty acids) [ Time Frame: 12 months (at 24 months of age) ]
    Plasma and red blood cell fatty acids levels in relation to dietary LCPUFA intake
  • Systolic and diastolic blood pressure (mmHg) [ Time Frame: 12 months (at baseline and 24 months of age) ]
    In clinic systolic and diastolic blood pressure in relation to LCPUFA status
  • Heart rate and heart rate variability [ Time Frame: 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 [ Time Frame: 12 months (at 24 months of age) ]
    Genetic variation in fatty acid desaturases in relation to LCPUFA status
  • Hemoglobin (g/dL) [ Time Frame: 12 months (at baseline and 24 months of age) ]
    Hemoglobin concentration in relation to diet
  • Ferritin (ng/ml) [ Time Frame: 12 months (at baseline and 24 months of age) ]
    Serum ferritin in relation to child diet
  • Choline metabolites (umol/L) [ Time Frame: 12 months (at baseline and 24 months of age) ]
    Plasma free choline, betaine, and dimethylglycine in relation to child diet
  • Folate (nmol/L) [ Time Frame: 12 months (at baseline and 24 months of age) ]
    Serum folate in relation to child diet
  • Vitamin B12 (pmol/L) [ Time Frame: 12 months (at baseline and 24 months of age) ]
    Serum vitamin B12 in relation to child diet
  • Vitamin D (nmol/L) [ Time Frame: 12 months (at baseline and 24 months of age) ]
    Serum vitamin D in relation to child diet
  • Supplements and supplemented foods [ Time Frame: 12 months (at baseline and age 18 and 24 months) ]
    Use of nutrient supplements and supplemented foods and child nutrient status.
  • Growth (weight, kg) [ Time Frame: 12 months (at baseline and age 18 and 24 months) ]
    Weight of at baseline, 18 and 24 months in relation to LCPUFA
  • Growth (height) [ Time Frame: 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) [ Time Frame: 12 months (at baseline and age 18 and 24 months) ]
    BMI at baseline, 18 and 24 months in relation to LCPUFA
  • Growth (waist circumference, cm) [ Time Frame: 12 months (at baseline and age 18 and 24 months) ]
    Waist circumference at baseline, 18 and 24 months in relation to LCPUFA
  • Incidence and duration of illness [ Time Frame: 12 months (at baseline and age 18 and 24 months) ]
    Parental reports of illness and duration
  • Physiological measures of blood pressure, heart rate and heart rate variability [ Time Frame: 12 months ]
    Distribution of physiological measures in relation to LCPUFA status
  • Genetic variation in fatty acid desaturases [ Time Frame: 12 months ]
    Genetic variation in fatty acid desaturases in relation to LCPUFA status
  • Nutrient status [ Time Frame: 12 months ]
    Measures of hemoglobin , ferritin, choline, folate, B12 and vitamin D in relation to child diet
  • Supplements and supplemented foods [ Time Frame: 12 months ]
    Use of nutrient supplements and supplemented foods and child nutrient status.
Not Provided
Not Provided
 
Essential Fatty Acid Nutrition For 1-2 Yr-Olds
Essential Fatty Acid Nutrition in Infants 1 to 2 Years-of-Age
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.
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).
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Infant Nutrition
  • Dietary Supplement: LCPUFA Supplement
    Children 12-13 months old will be assigned at random to receive either a nutrition supplement containing LCPUFA or a placebo until 24 months-of-age
  • Dietary Supplement: Placebo
    Children 12-13 months old will be assigned at random to receive either a nutrition supplement containing LCPUFA or a placebo until 24 months-of-age
  • Active Comparator: 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).
    Intervention: Dietary Supplement: LCPUFA Supplement
  • Placebo Comparator: A Placebo
    400 mg/day corn oil
    Intervention: Dietary Supplement: Placebo
Devlin AM, Chau CMY, Dyer R, Matheson J, McCarthy D, Yurko-Mauro K, Innis SM, Grunau RE. Developmental Outcomes at 24 Months of Age in Toddlers Supplemented with Arachidonic Acid and Docosahexaenoic Acid: Results of a Double Blind Randomized, Controlled Trial. Nutrients. 2017 Sep 6;9(9). pii: E975. doi: 10.3390/nu9090975.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
133
December 2016
August 2015   (Final data collection date for primary outcome measure)

Inclusion criteria:

  • term gestation (37-41 weeks gestation and 2500g or more at birth)
  • single birth
  • English as the primary language in the home
  • non-smoking home environment
  • a healthy infant not yet 13 months-of-age, who is not currently breast-fed or fed infant formula with ARA and DHA.
  • primary milk source is cows' milk, cows' milk substitutes, or other milk substitutes containing no supplemental fatty acids from enrollment to 24 months-of age.
  • the infant has no known food allergies, metabolic, neurological, genetic, or immune disorders that are likely, in the opinion of the investigator to impact the outcome measures in this study.
  • the infant has not been fatty acid or oil, including fish oil supplements and there is no intent to provide these supplements during the study.
  • the infant has no history of hospitalization, growth failure or any other event which in the opinion of the investigator is likely to impact the outcome measures in this study.

Exclusion Criteria:

  • any infant that does not meet the inclusion criteria will not be included in this study.
Sexes Eligible for Study: All
12 Months to 13 Months   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT01263912
H09-02028
Yes
Not Provided
Not Provided
Angela Devlin, University of British Columbia
University of British Columbia
  • DSM Nutritional Products, Inc.
  • DSM Food Specialties
Principal Investigator: Angela Devlin, PhD The University of British Columbia
University of British Columbia
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP