- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01263912
Essential Fatty Acid Nutrition For 1-2 Yr-Olds
November 29, 2017 updated by: Angela Devlin, University of British Columbia
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
133
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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British Columbia
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Vancouver, British Columbia, Canada, V5Z4H4
- BC Children's Hospital Research Institute, University of British Columbia
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 1 year (CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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).
|
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
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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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
12 months (at 24 months of age)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
12 months (at 24 months of age)
|
Systolic and diastolic blood pressure (mmHg)
Time Frame: 12 months (at baseline and 24 months of age)
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In clinic systolic and diastolic blood pressure in relation to LCPUFA status
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12 months (at baseline and 24 months of age)
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Heart rate and heart rate variability
Time Frame: 12 months (at baseline and 24 months of age)
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Heart rate and heart rate variability in relation to LCPUFA status
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12 months (at baseline and 24 months of age)
|
Genetic variation in fatty acid desaturases
Time Frame: 12 months (at 24 months of age)
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Genetic variation in fatty acid desaturases in relation to LCPUFA status
|
12 months (at 24 months of age)
|
Hemoglobin (g/dL)
Time Frame: 12 months (at baseline and 24 months of age)
|
Hemoglobin concentration in relation to diet
|
12 months (at baseline and 24 months of age)
|
Ferritin (ng/ml)
Time Frame: 12 months (at baseline and 24 months of age)
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Serum ferritin in relation to child diet
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12 months (at baseline and 24 months of age)
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Choline metabolites (umol/L)
Time Frame: 12 months (at baseline and 24 months of age)
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Plasma free choline, betaine, and dimethylglycine in relation to child diet
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12 months (at baseline and 24 months of age)
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Folate (nmol/L)
Time Frame: 12 months (at baseline and 24 months of age)
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Serum folate in relation to child diet
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12 months (at baseline and 24 months of age)
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Vitamin B12 (pmol/L)
Time Frame: 12 months (at baseline and 24 months of age)
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Serum vitamin B12 in relation to child diet
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12 months (at baseline and 24 months of age)
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Vitamin D (nmol/L)
Time Frame: 12 months (at baseline and 24 months of age)
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Serum vitamin D in relation to child diet
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12 months (at baseline and 24 months of age)
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Supplements and supplemented foods
Time Frame: 12 months (at baseline and age 18 and 24 months)
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Use of nutrient supplements and supplemented foods and child nutrient status.
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12 months (at baseline and age 18 and 24 months)
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Growth (weight, kg)
Time Frame: 12 months (at baseline and age 18 and 24 months)
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Weight of at baseline, 18 and 24 months in relation to LCPUFA
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12 months (at baseline and age 18 and 24 months)
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Growth (height)
Time Frame: 12 months (at baseline and age 18 and 24 months)
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Height at baseline, 18 and 24 months in relation to LCPUFA
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12 months (at baseline and age 18 and 24 months)
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Growth (BMI, kg/m2)
Time Frame: 12 months (at baseline and age 18 and 24 months)
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BMI at baseline, 18 and 24 months in relation to LCPUFA
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12 months (at baseline and age 18 and 24 months)
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Growth (waist circumference, cm)
Time Frame: 12 months (at baseline and age 18 and 24 months)
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Waist circumference at baseline, 18 and 24 months in relation to LCPUFA
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12 months (at baseline and age 18 and 24 months)
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Incidence and duration of illness
Time Frame: 12 months (at baseline and age 18 and 24 months)
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Parental reports of illness and duration
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12 months (at baseline and age 18 and 24 months)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Angela Devlin, PhD, The University of British Columbia
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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):975. doi: 10.3390/nu9090975.
- Wiedeman AM, Dyer RA, McCarthy D, Yurko-Mauro K, Innis SM, Devlin AM. Biomarkers of Docosahexaenoic Acid but Not Arachidonic Acid Reflect Dietary Intakes in Toddlers at Ages 1 and 2 Years Who Are Not Meeting Dietary Recommendations. J Nutr. 2020 Mar 1;150(3):518-525. doi: 10.1093/jn/nxz280.
- Wiedeman AM, Chau CMY, Grunau RE, McCarthy D, Yurko-Mauro K, Dyer RA, Innis SM, Devlin AM. Plasma Betaine Is Positively Associated with Developmental Outcomes in Healthy Toddlers at Age 2 Years Who Are Not Meeting the Recommended Adequate Intake for Dietary Choline. J Nutr. 2018 Aug 1;148(8):1309-1314. doi: 10.1093/jn/nxy108.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2010
Primary Completion (ACTUAL)
August 1, 2015
Study Completion (ACTUAL)
December 1, 2016
Study Registration Dates
First Submitted
December 17, 2010
First Submitted That Met QC Criteria
December 20, 2010
First Posted (ESTIMATE)
December 21, 2010
Study Record Updates
Last Update Posted (ACTUAL)
December 2, 2017
Last Update Submitted That Met QC Criteria
November 29, 2017
Last Verified
November 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- H09-02028
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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