Effect of Long-Chain Polyunsaturated Fatty Acid Supplementation on Toddler Cognition
|ClinicalTrials.gov Identifier: NCT00982462|
Recruitment Status : Completed
First Posted : September 23, 2009
Last Update Posted : April 25, 2017
|Condition or disease||Intervention/treatment||Phase|
|Infant Development||Dietary Supplement: Docosahexaenoic acid (DHA) and arachidonic acid (ARA) Dietary Supplement: Corn oil placebo||Not Applicable|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||116 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Effects of Extended Duration of Long-Chain Polyunsaturated Fatty Acid (LCP)-Supplementation on Neurological and Immunological Development in Toddlers|
|Actual Study Start Date :||January 20, 2011|
|Actual Primary Completion Date :||June 29, 2016|
|Actual Study Completion Date :||June 29, 2016|
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.
Experimental: 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.
Dietary Supplement: 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.
- Maturation of cognition as assessed by the Bayley Scales of Infant Development at 24 months of age [ Time Frame: 12 months intervention ]
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00982462
|United States, Texas|
|Retina Foundation of the Southwest|
|Dallas, Texas, United States, 75231|
|Principal Investigator:||Eileen E Birch, PhD||Retina Foundation of the Southwest|
|Principal Investigator:||Dennis R Hoffman, PhD||Retina Foundation of the Southwest|