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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
DSM Nutritional Products, Inc.
Information provided by (Responsible Party):
Dennis Hoffman, Retina Foundation of the Southwest
ClinicalTrials.gov Identifier:
NCT00982462
First received: September 21, 2009
Last updated: January 17, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Infant Development
Dietary Supplement: Docosahexaenoic acid (DHA) and arachidonic acid (ARA)
Dietary Supplement: Corn oil placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effects of Extended Duration of Long-Chain Polyunsaturated Fatty Acid (LCP)-Supplementation on Neurological and Immunological Development in Toddlers

Resource links provided by NLM:


Further study details as provided by Retina Foundation of the Southwest:

Primary Outcome Measures:
  • Maturation of cognition as assessed by the Bayley Scales of Infant Development at 24 months of age [ Time Frame: 12 months intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Maturation of cognition as assessed by the Wechsler Preschool and Primary Scale of Intelligence at 36 months of age [ Time Frame: After 24 months of intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 114
Study Start Date: October 2010
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Corn oil placebo
Micro-encapsulated powder containing corn oil placebo.
Dietary Supplement: Corn oil placebo
Micro-encapsulated powder containing corn oil as the placebo.
Other Names:
  • Long-chain polyunsaturated fatty acids
  • Omega-6 fatty acids
Experimental: Long-chain polyunsaturated fatty acids
Micro-encapsulated powder containing 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.
Dietary Supplement: Docosahexaenoic acid (DHA) and arachidonic acid (ARA)
Micro-encapsulated powder containing 1:1 ratio of DHA to ARA. 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.
Other Names:
  • Long-chain polyunsaturated fatty acids
  • omega-3 fatty acids
  • omega-6 fatty acids

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).
  Eligibility

Ages Eligible for Study:   351 Days to 379 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00982462

Locations
United States, Texas
Retina Foundation of the Southwest
Dallas, Texas, United States, 75231
Sponsors and Collaborators
Retina Foundation of the Southwest
DSM Nutritional Products, Inc.
Investigators
Principal Investigator: Eileen E Birch, PhD Retina Foundation of the Southwest
Principal Investigator: Dennis R Hoffman, PhD Retina Foundation of the Southwest
  More Information

Additional Information:
No publications provided

Responsible Party: Dennis Hoffman, Sr Research Scientist, Retina Foundation of the Southwest
ClinicalTrials.gov Identifier: NCT00982462     History of Changes
Other Study ID Numbers: DSM #2009-1024
Study First Received: September 21, 2009
Last Updated: January 17, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Retina Foundation of the Southwest:
cognition
vision
immunology
DHA
ARA
infant
nutrition

ClinicalTrials.gov processed this record on October 23, 2014