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Essential Fatty Acid Nutrition For 1-2 Yr-Olds

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01263912
First Posted: December 21, 2010
Last Update Posted: December 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
DSM Nutritional Products, Inc.
DSM Food Specialties
Information provided by (Responsible Party):
Angela Devlin, University of British Columbia
  Purpose
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.

Condition Intervention
Infant Nutrition Dietary Supplement: LCPUFA Supplement Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Essential Fatty Acid Nutrition in Infants 1 to 2 Years-of-Age

Resource links provided by NLM:


Further study details as provided by Angela Devlin, University of British Columbia:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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


Enrollment: 133
Study Start Date: December 2010
Study Completion Date: December 2016
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
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
Placebo Comparator: A Placebo
400 mg/day corn oil
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

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).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Months to 13 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01263912


Locations
Canada, British Columbia
BC Children's Hospital Research Institute, University of British Columbia
Vancouver, British Columbia, Canada, V5Z4H4
Sponsors and Collaborators
University of British Columbia
DSM Nutritional Products, Inc.
DSM Food Specialties
Investigators
Principal Investigator: Angela Devlin, PhD The University of British Columbia
  More Information

Additional Information:
Publications:
Responsible Party: Angela Devlin, Principle Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT01263912     History of Changes
Other Study ID Numbers: H09-02028
First Submitted: December 17, 2010
First Posted: December 21, 2010
Last Update Posted: December 1, 2017
Last Verified: November 2017

Keywords provided by Angela Devlin, University of British Columbia:
Polyunsaturated fatty acids
Cognitive development
Growth
Infection