Infant NutritionNCT01263912
Essential Fatty Acid Nutrition For 1-2 Yr-Olds
A study testing LCPUFA Supplement in people with Infant Nutrition, run by University of British Columbia at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 12 to 13 monthsHealthy volunteers can take part
- Conditions the study is for
- Infant Nutrition
- What is being tested?
- LCPUFA Supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 133 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2010to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 13 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- any infant that does not meet the inclusion criteria will not be included in this study.
Trial locations and contacts
1 site in 1 country.
Canada1 site
BC Children's Hospital Research Institute, University of British Columbia
Vancouver, British Columbia, V5Z4H4
About this study
Official title: 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.
Read the 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).
- Conditions
- Infant Nutrition
- Being tested
- LCPUFA Supplement, Placebo
- Keywords
- Polyunsaturated fatty acids, Cognitive development, Growth, Infection
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LCPUFA SupplementDietary 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
PlaceboDietary 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
| Study group | Role | What they receive |
|---|---|---|
| LCPUFA Supplement | Active comparator | 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). Receives: Dietary Supplement: LCPUFA Supplement |
| A Placebo | Placebo comparator | 400 mg/day corn oil Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Developmental test scores
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.
Measured: 12 months (at 24 months of age)
Secondary outcomes (16)
Plasma and Red Blood Cell fatty acids (% total fatty acids)
Plasma and red blood cell fatty acids levels in relation to dietary LCPUFA intake
Measured: 12 months (at 24 months of age)
Systolic and diastolic blood pressure (mmHg)
In clinic systolic and diastolic blood pressure in relation to LCPUFA status
Measured: 12 months (at baseline and 24 months of age)
Heart rate and heart rate variability
Heart rate and heart rate variability in relation to LCPUFA status
Measured: 12 months (at baseline and 24 months of age)
Genetic variation in fatty acid desaturases
Genetic variation in fatty acid desaturases in relation to LCPUFA status
Measured: 12 months (at 24 months of age)
Hemoglobin (g/dL)
Hemoglobin concentration in relation to diet
Measured: 12 months (at baseline and 24 months of age)
Ferritin (ng/ml)
Serum ferritin in relation to child diet
Measured: 12 months (at baseline and 24 months of age)
Choline metabolites (umol/L)
Plasma free choline, betaine, and dimethylglycine in relation to child diet
Measured: 12 months (at baseline and 24 months of age)
Folate (nmol/L)
Serum folate in relation to child diet
Measured: 12 months (at baseline and 24 months of age)
Vitamin B12 (pmol/L)
Serum vitamin B12 in relation to child diet
Measured: 12 months (at baseline and 24 months of age)
Vitamin D (nmol/L)
Serum vitamin D in relation to child diet
Measured: 12 months (at baseline and 24 months of age)
Supplements and supplemented foods
Use of nutrient supplements and supplemented foods and child nutrient status.
Measured: 12 months (at baseline and age 18 and 24 months)
Growth (weight, kg)
Weight of at baseline, 18 and 24 months in relation to LCPUFA
Measured: 12 months (at baseline and age 18 and 24 months)
Growth (height)
Height at baseline, 18 and 24 months in relation to LCPUFA
Measured: 12 months (at baseline and age 18 and 24 months)
Growth (BMI, kg/m2)
BMI at baseline, 18 and 24 months in relation to LCPUFA
Measured: 12 months (at baseline and age 18 and 24 months)
Growth (waist circumference, cm)
Waist circumference at baseline, 18 and 24 months in relation to LCPUFA
Measured: 12 months (at baseline and age 18 and 24 months)
Incidence and duration of illness
Parental reports of illness and duration
Measured: 12 months (at baseline and age 18 and 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionAug 2015
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Infant NutritionStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- dsm-firmenich Switzerland AG, DSM Food Specialties
- Responsible party
- Principal investigator, Angela Devlin, University of British Columbia
- Investigators
- Angela Devlin, PhD, Principal investigator, The University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01263912
- Sponsor's protocol ID
- H09-02028
- Status last verified
- Nov 2017
- First submitted
- 17 Dec 2010
- Last updated
- 2 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 28878181Wiedeman 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.
PubMed 31754697Wiedeman 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.
PubMed 29986040
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Essential Fatty Acid Nutrition in Infants 1 to 2 Years-of-Age
- ClinicalTrials.gov ID
- NCT01263912
- Acronym / sponsor ID
- H09-02028
- Conditions
- Infant Nutrition
- Keywords
- Polyunsaturated fatty acids, Cognitive development, Growth, Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- dsm-firmenich Switzerland AG, DSM Food Specialties
- Study start
- Dec 2010
- Primary completion
- Aug 2015 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 21 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LCPUFA Supplement | Active comparator | Dietary Supplement: LCPUFA SupplementDHA/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). |
| A Placebo | Placebo comparator | Dietary Supplement: Placebo400 mg/day corn oil |
Who may qualify
- Ages
- 12 to 13 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (1 listed)
- any infant that does not meet the inclusion criteria will not be included in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LCPUFA SupplementChildren 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 | LCPUFA Supplement |
| PlaceboChildren 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 | A Placebo |
Primary outcome
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.
16 secondary outcomes
Plasma and Red Blood Cell fatty acids (% total fatty acids)
Time frame: 12 months (at 24 months of age)
Systolic and diastolic blood pressure (mmHg)
Time frame: 12 months (at baseline and 24 months of age)
Heart rate and heart rate variability
Time frame: 12 months (at baseline and 24 months of age)
Genetic variation in fatty acid desaturases
Time frame: 12 months (at 24 months of age)
Hemoglobin (g/dL)
Time frame: 12 months (at baseline and 24 months of age)
Ferritin (ng/ml)
Time frame: 12 months (at baseline and 24 months of age)
Choline metabolites (umol/L)
Time frame: 12 months (at baseline and 24 months of age)
Folate (nmol/L)
Time frame: 12 months (at baseline and 24 months of age)
Vitamin B12 (pmol/L)
Time frame: 12 months (at baseline and 24 months of age)
Vitamin D (nmol/L)
Time frame: 12 months (at baseline and 24 months of age)
Supplements and supplemented foods
Time frame: 12 months (at baseline and age 18 and 24 months)
Growth (weight, kg)
Time frame: 12 months (at baseline and age 18 and 24 months)
Growth (height)
Time frame: 12 months (at baseline and age 18 and 24 months)
Growth (BMI, kg/m2)
Time frame: 12 months (at baseline and age 18 and 24 months)
Growth (waist circumference, cm)
Time frame: 12 months (at baseline and age 18 and 24 months)
Incidence and duration of illness
Time frame: 12 months (at baseline and age 18 and 24 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2017.
- Results publication: PubMed 28878181Devlin 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.
- Derived from this study: PubMed 31754697Wiedeman 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.
- Derived from this study: PubMed 29986040Wiedeman 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.
Related trials for Infant Nutrition
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
Not yet recruitingObservational study
Early Nutrition and Heart Structure and Function in Preterm Infants During the First Year of Life
Cardiac Abnormalities, Nutrient Intake
RecruitingObservational study
Longitudinal Prospective Study of Maternal and Child Nutrition in Arkansas
Maternal Nutrition, Infant Nutrition
RecruitingObservational study
Improving Nutrition for Babies Born by Caesarean Section
Breastfeeding Mothers of Legal Age, Their Babies Under 6 Months Old Born Vaginally
Recruiting
Protocol-driven Nutrition in Preterm Infants
Preterm Infants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angela Devlin, PhD principal investigator
The University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LCPUFA Supplement in people with Infant Nutrition, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Developmental test scores (time frame: 12 months (at 24 months of age)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01263912, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2017.