EFA Nutrition 1-2 Yr-Olds

This study is currently recruiting participants.
Verified December 2013 by University of British Columbia
Sponsor:
Collaborators:
Martek Biosciences Corporation
DSM Food Specialties
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01263912
First received: December 17, 2010
Last updated: December 10, 2013
Last verified: December 2013
  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: Nutrition supplement containing Long Chain Polyunsaturated Fatty Acids (LCPUFA)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
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 University of British Columbia:

Primary Outcome Measures:
  • Developmental test scores [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Distribution of developmental test scores at 18 and 24 months in relation to LCPUFA status

  • Growth and growth quality [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Distribution of growth measures at 18 and 24 months in relation to LCPUFA status

  • Incidence and duration of illness [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Parental reports of illness and duration


Secondary Outcome Measures:
  • Physiological measures of blood pressure, heart rate and heart rate variability [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Distribution of physiological measures in relation to LCPUFA status

  • Genetic variation in fatty acid desaturases [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Genetic variation in fatty acid desaturases in relation to LCPUFA status

  • Nutrient status [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Measures of hemoglobin , ferritin, choline, folate, B12 and vitamin D in relation to child diet

  • Supplements and supplemented foods [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Use of nutrient supplements and supplemented foods and child nutrient status.


Estimated Enrollment: 200
Study Start Date: December 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A nutrition supplement containing LCPUFA Dietary Supplement: Nutrition supplement containing Long Chain Polyunsaturated Fatty Acids (LCPUFA)
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 Dietary Supplement: Nutrition supplement containing Long Chain Polyunsaturated Fatty Acids (LCPUFA)
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

Ages Eligible for Study:   12 Months to 13 Months
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01263912

Locations
Canada, British Columbia
Child & Family Research Institute, CF Clinic, BC Children's Hospital Recruiting
Vancouver, British Columbia, Canada
Contact: Sheil M Innis, Dr.    604-875-2431    sinnis@interchange.ubc.ca   
Principal Investigator: Sheila M Innis, Dr.         
Sponsors and Collaborators
University of British Columbia
Martek Biosciences Corporation
DSM Food Specialties
Investigators
Principal Investigator: Sheila M Innis, Dr. The University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01263912     History of Changes
Other Study ID Numbers: H09-02028
Study First Received: December 17, 2010
Last Updated: December 10, 2013
Health Authority: Canada: Health Canada

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

ClinicalTrials.gov processed this record on April 23, 2014