Track topics on Twitter Track topics that are important to you
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).
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Healthy Term Infants
Docosahexaenoic acid (DHA) and arachidonic acid (ARA), Corn oil placebo
Retina Foundation of the Southwest
Not yet recruiting
Retina Foundation of the Southwest
Published on BioPortfolio: 2014-08-27T03:19:10-0400
The purpose of this study is to test the hypothesis that dietary supplementation with the omega-3 fatty acid docosahexaenoic acid (DHA) improves the behavior of children with autism.
The purpose of this study is to determine the kinetics of 13C-eicosapentaenoic acid (EPA) and 13C-arachidonic acid (AA) in young and older participants
To examine whether Docosahexaenoic Acid (DHA) and Docosahexaenoic + Eicosapentaenoic Acids (DHA+EPA) supplementation in addition to National Cholesterol Education Program Step I Diet in Hy...
This is a feasibility study to determine if it will be possible to conduct a larger study of the effect of docosahexaenoic acid (DHA), an omega fatty acid, on increased length of gestation...
The purpose of this study is to evaluate if enteral docosahexaenoic acid (DHA) administration attenuates the inflammatory cytokines and improve clinical outcomes in neonates who underwent ...
A wealth of information on the functional roles of docosahexaenoic acid (DHA) and arachidonic acid (ARA) from cellular, animal, and human studies is available. Yet, there remains a lack of cohesion in...
Animal models support dietary omega-3 fatty acids protection against abdominal aortic aneurysm (AAA), but clinical data are scarce. The sum of red blood cell proportions of the omega-3 eicosapentaenoi...
Long chain n-3 fatty acid supplementation may modulate septic shock-induced host response to pathogen-induced sepsis. The composition of lipid emulsions for parenteral nutrition however remains a real...
Macrophage polarization determines the timing for the switch from the inflammation phase to the inflammation resolution phase after acute myocardial infarction. The aim of the present study was to inv...
Abnormal activity of atherosclerotic endothelial cells paving luminal surface of blood vessels has been described in many diseases. It has been reported that natural polyunsaturated fatty acids such a...
Prostaglandin-like compounds produced by free radical-induced peroxidation of DOCOSAHEXAENOIC ACIDS, which are highly enriched in the brain. Formation is analogous to ISOPROSTANES formation from ARACHIDONIC ACID.
A 20-carbon-chain fatty acid, unsaturated at positions 8, 11, and 14. It differs from arachidonic acid, 5,8,11,14-eicosatetraenoic acid, only at position 5.
A 20-carbon unsaturated fatty acid containing 4 alkyne bonds. It inhibits the enzymatic conversion of arachidonic acid to prostaglandins E(2) and F(2a).
An unsaturated, essential fatty acid. It is found in animal and human fat as well as in the liver, brain, and glandular organs, and is a constituent of animal phosphatides. It is formed by the synthesis from dietary linoleic acid and is a precursor in the biosynthesis of prostaglandins, thromboxanes, and leukotrienes.
Eighteen-carbon cyclopentyl polyunsaturated fatty acids derived from ALPHA-LINOLENIC ACID via an oxidative pathway analogous to the EICOSANOIDS in animals. Biosynthesis is inhibited by SALICYLATES. A key member, jasmonic acid of PLANTS, plays a similar role to ARACHIDONIC ACID in animals.
Pediatrics is the general medicine of childhood. Because of the developmental processes (psychological and physical) of childhood, the involvement of parents, and the social management of conditions at home and at school, pediatrics is a specialty. With ...
Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...