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Completed

NCT Number: NCT01263912

Essential Fatty Acid Nutrition For 1-2 Yr-Olds

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.

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Key information

Age range

12 month–13 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

BC Children's Hospital Research Institute, University of British Columbia

Vancouver, British Columbia, V5Z4H4, Canada

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LCPUFA Supplement

Dietary 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

Placebo

Dietary 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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. Hemoglobin (g/dL)

    Time frame: 12 months (at baseline and 24 months of age)

    Hemoglobin concentration in relation to diet

  6. Ferritin (ng/ml)

    Time frame: 12 months (at baseline and 24 months of age)

    Serum ferritin in relation to child diet

  7. 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

  8. Folate (nmol/L)

    Time frame: 12 months (at baseline and 24 months of age)

    Serum folate in relation to child diet

  9. Vitamin B12 (pmol/L)

    Time frame: 12 months (at baseline and 24 months of age)

    Serum vitamin B12 in relation to child diet

  10. Vitamin D (nmol/L)

    Time frame: 12 months (at baseline and 24 months of age)

    Serum vitamin D in relation to child diet

  11. 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.

  12. 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

  13. 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

  14. 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

  15. 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

  16. Incidence and duration of illness

    Time frame: 12 months (at baseline and age 18 and 24 months)

    Parental reports of illness and duration

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • DSM Food Specialties
  • dsm-firmenich Switzerland AG

Registry information

Official study title

Essential Fatty Acid Nutrition in Infants 1 to 2 Years-of-Age

Important dates

Study start
2010
Primary completion
2015
Study completion
2016
First posted
Dec 21, 2010
Registry last updated
Dec 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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