Essential Fatty Acid Nutrition For 1-2 Yr-Olds

NCT01263912 | Completed DMC

• 1 other identifier: H09-02028
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Infant Nutrition

Keywords

Polyunsaturated fatty acids; Cognitive development; Growth; Infection

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months (at 24 months of age)

Secondary Outcomes (16)

• Plasma and Red Blood Cell fatty acids (% total fatty acids)

  12 months (at 24 months of age)

• Systolic and diastolic blood pressure (mmHg)

  12 months (at baseline and 24 months of age)

• Heart rate and heart rate variability

  12 months (at baseline and 24 months of age)

• Genetic variation in fatty acid desaturases

  12 months (at 24 months of age)

• Hemoglobin (g/dL)

  12 months (at baseline and 24 months of age)

Study Arms (2)

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).

Dietary Supplement: LCPUFA Supplement

A Placebo

PLACEBO COMPARATOR

400 mg/day corn oil

Dietary Supplement: Placebo

Interventions

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

LCPUFA Supplement

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

A Placebo

Eligibility Criteria

• Age: 12 Months - 13 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of British Columbia: lead
• DSM Nutritional Products, Inc.: collaborator
• DSM Food Specialties: collaborator

Study Sites (1)

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

Vancouver, British Columbia, V5Z4H4, Canada

Location

Related Publications (3)

• 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.

  PMID: 28878181 RESULT

• 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.

  PMID: 31754697 DERIVED

• 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.

  PMID: 29986040 DERIVED

MeSH Terms

Conditions

Infections

Study Officials

• Angela Devlin, PhD

  The University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: December 17, 2010
• First Posted: December 21, 2010
• Study Start: December 1, 2010
• Primary Completion: August 1, 2015
• Study Completion: December 1, 2016
• Last Updated: December 2, 2017

Record last verified: 2017-11

Locations

CA (1)