Effect of Long-Chain Polyunsaturated Fatty Acid Supplementation on Toddler Cognition

NCT ID: NCT00982462

Last Updated: 2017-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-20
• Study Completion Date: 2016-06-29

Brief Summary

The hypothesis to be examined is that dietary LCP-supplementation in the second and third years of life will improve cognitive and visual maturation in early childhood.

Detailed Description

A total number of 114 toddlers at 12 months ± 2 weeks of age will be recruited and randomized to two groups (placebo or LCP-supplemented). Cognition, visual function, anthropometric, immunologic and biochemical status, and health will be assessed upon entry to evaluate equality between study groups.

The primary outcome measure for Part A will be maturation of cognition at 24 months ± 2 weeks of age (after 12 months of LCP dietary intervention) as assessed by the Bayley Scales of Infant Development (BSID)-version III. In Part B, maturation of cognition at 36 months of age (after 24 months of LCP dietary intervention) will be assessed using the Wechsler Preschool and Primary Scale of Intelligence (WPPSI-III).

The study supplements are (1) a micro-encapsulated powder containing a 1:1 ratio of the omega-3 fatty acid, docosahexaenoic acid (DHA) and the omega-6 fatty acid, arachidonic acid (ARA) from algal and fungal sources, respectively; and (2) a micro-encapsulated powder containing corn oil placebo. Two foil-packets containing either active intervention or placebo will provide 200mg DHA and 200mg ARA or 400 mg placebo oil per day to the toddler. Two packets of the powders will be added each day to a selection of recommended foods (e.g., yogurt). The duration of treatment will be from 12 to 24 months of age in Part A and in Part B will be from 24 to 36 months and followed to 42 months of age.

Secondary outcome measures are:

• COGNITION: Peabody Picture Vocabulary Test (PPVT-II; 42 mo) and the Bracken Basic Concept Scale (42 mo).
• VISION: Grating & stereoacuity (12, 24 & 36 mo); letter acuity at 36 mo.
• ANTHROPOMETRICS, HEALTH INDICES & DIETARY STATUS: Weight, height, head circumference, waist & hip measures, body mass index (BMI), skin fold fat deposition, heart rate (HR), blood pressure (BP), omega-3-targeted food questionnaire (at 12,18, 24, 30, 36, & 42 mo), childhood illnesses from birth to 36 months with emphasis on allergy and asthma chart review and a questionnaire to determine family history of asthma and allergy as well as the child's exposure to smoking (12, 24 & 36 mo).
• EXECUTIVE FUNCTION: Behavior Rating Inventory of Executive Function - Preschool Version (BRIEF-P questionnaire; 24 & 36 mo), Kansas Reflection-Impulsivity Scale for Preschoolers (KRISP; 42 mo), Dimensional Change Card Sort (DCCS; 42 mo), three Stroop Tasks (42 mo), the Grass/Snow task (42 months), and the Day/Night Task (42 months).
• SLEEP: Brief Infant Sleep Questionnaire (BSIQ;12 & 24 mo), Children's Sleep Habits Questionnaire (CSHQ; 36 & 42 mo).
• IMMUNE FUNCTION: plasma cytokine levels (12 & 24 mo), skin prick tests for specific IgEs (12 & 24 mo), plasma total IgE, salivary (secretory) IgA (12 & 24 mo), plasma C-reactive protein (CRP;12 & 24 mo).
• INDICES OF NEURAL TISSUE COMPOSITION AND COMPLIANCE: Total RBC fatty acid analysis (12 & 24 mo), buccal cheek cell phospholipids fatty acid analysis (12, 24, & 36 mo).

Conditions

Infant Development

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Corn oil placebo

Micro-encapsulated powder containing corn oil placebo.

Group Type: PLACEBO_COMPARATOR

Corn oil placebo

Intervention Type: DIETARY_SUPPLEMENT

Micro-encapsulated powder containing corn oil as the placebo.

Long-chain polyunsaturated fatty acids

Micro-encapsulated powder containing 1:1 ratio of the omega-3 long-chain polyunsaturated fatty acids, docosahexaenoic acid (DHA) and the omega-6 fatty acid, arachidonic acid (ARA) from algal and fungal sources, respectively.

Group Type: EXPERIMENTAL

Docosahexaenoic acid (DHA) and arachidonic acid (ARA)

Intervention Type: DIETARY_SUPPLEMENT

Micro-encapsulated powder containing the long-chain polyunsaturated fatty acids, DHA to ARA in a 1:1 ratio. Two foil-packets containing active intervention (200mg DHA+200mg ARA) or placebo (400 mg corn oil) per day added to a selection of recommended foods.

Interventions

Docosahexaenoic acid (DHA) and arachidonic acid (ARA)

Micro-encapsulated powder containing the long-chain polyunsaturated fatty acids, DHA to ARA in a 1:1 ratio. Two foil-packets containing active intervention (200mg DHA+200mg ARA) or placebo (400 mg corn oil) per day added to a selection of recommended foods.

Intervention Type: DIETARY_SUPPLEMENT

Corn oil placebo

Micro-encapsulated powder containing corn oil as the placebo.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Long-chain polyunsaturated fatty acids; omega-3 fatty acids; omega-6 fatty acids; Long-chain polyunsaturated fatty acids; Omega-6 fatty acids

Eligibility Criteria

Inclusion Criteria

• Toddlers (12 months ± 2 weeks of age at randomization).
• Breast-fed or formula-fed during the first 12 months of life.
• Mother plans to discontinue breast-feeding/formula feeding by 13 months of age.
• Full-term at birth (37-42 weeks post-conception).
• English as the primary language in the home.

Exclusion Criteria

• History of underlying disease or congenital malformation which, in the opinion of the Investigator, is likely to interfere with the normal growth and development of the participant or the evaluation of the participant.
• Toddler weighing <5% or >95% of the normative values in Centers for Disease Control and Prevention (CDC) growth charts released in 2000 (www.cdc.gov/growthcharts/).
• Evidence of poor food intake at time of randomization.
• Parent(s) currently supplement or plan to supplement child with >100 mg DHA per day (fish, fish oil, capsules or chewables).

• Minimum Eligible Age: 351 Days
• Maximum Eligible Age: 379 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

DSM Nutritional Products, Inc.

INDUSTRY

Sponsor Role: collaborator

Retina Foundation of the Southwest

OTHER

Sponsor Role: lead

Responsible Party

Dennis Hoffman

Sr Research Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eileen E Birch, PhD

Role: PRINCIPAL_INVESTIGATOR

Retina Foundation of the Southwest

Dennis R Hoffman, PhD

Role: PRINCIPAL_INVESTIGATOR

Retina Foundation of the Southwest

Locations

Retina Foundation of the Southwest

Dallas, Texas, United States

Countries

United States

Related Links

http://www.retinafoundation.org

webpage for Retina Foundation of the Southwest

Other Identifiers

DSM #2009-1024

Identifier Type: -

Identifier Source: org_study_id