Effects of Docosahexaenoic Acid (DHA) on Cognitive Function in Children 4 Years of Age
The primary objective of this study is to determine whether a 4-month period of supplementation with 400 mg/day of docosahexaenoic acid (DHA) provided from chewable softgel capsules containing bubblegum flavored microalgal oil (DHASCO-S) versus placebo improves one or more cognitive measures of attention, memory, processing speed, and error rate in healthy children 4 years of age.
The secondary objectives are to measure the safety and tolerability of the DHA dose administered and to measure blood DHA levels before and after supplementation.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of DHA on Cognitive Functions in Preschool Children|
- Leiter Test of Sustained Attention
- Kiddie Continuous Performance Test (kCAP)
- Peabody Picture Vocabulary Test
- Day-Night Stroop Test
- Safety and tolerability of the DHA dose
- Blood DHA levels before and after DHA supplementation
|Study Start Date:||May 2006|
|Study Completion Date:||September 2007|
DHA is the primary omega-3 fatty acid present in the brain and retina and plays crucial structural and functional roles in these issues. The primary dietary source of DHA is fatty fish (e.g., salmon, herring, tuna). The American diet provides one of the lowest levels of omega-3 fatty acids of most industrialized nations. Children between the ages of 1 and 5 years consume only 30 to 50 mg DHA per day despite high requirements for this nutrient to support growth and tissue turnover.
Studies with human infants have reported visual and cognitive benefits of DHA supplementation in early life. Reported benefits include significant improvements on tests of visual acuity during infancy, psychomotor or mental development in the first two years of life, and problem-solving and sustained attention around 5 years of age.
Few studies have evaluated the effect that DHA supplementation has on the cognitive function of older children. Studies that considered DHA supplementation in children 4-12 years of age with attention-deficit/hyperactivity disorder (ADHD) or other developmental disorders have shown improvements on several measures of attention, behavior, and executive function.
Given the estimated high requirements of DHA to support growth and maintenance of the brain, the low consumption of DHA by American children, and the evidence from human and animal studies that DHA status affects the functional capacity of the central nervous system, there is a reasonable expectation that DHA supplementation administered to preschool-aged children will improve performance on tests of attention, memory, processing speed, and error rate.
|United States, California|
|Impact Clinical Trials|
|Los Angeles, California, United States, 90010|
|United States, Georgia|
|Clinical Research Atlanta|
|Stockbridge, Georgia, United States, 30281|
|United States, Illinois|
|Northern Illinois Research Associates|
|Dekalb, Illinois, United States, 60135|
|United States, Kentucky|
|Owensboro, Kentucky, United States, 42301|
|United States, Nevada|
|Clinical Research Center of Nevada|
|Las Vegas, Nevada, United States, 89104|
|United States, Oklahoma|
|Eminence Research, LLC|
|Oklahoma City, Oklahoma, United States, 73118|
|United States, Tennessee|
|Prevention and Strengthening Solutions, Inc.|
|Humboldt, Tennessee, United States, 38343|
|United States, Texas|
|Southwest Children's Research Associates|
|San Antonio, Texas, United States, 78229|
|United States, Virginia|
|Charlottesville Medical Research|
|Charlottesville, Virginia, United States, 22911|
|Children's Hospital of the King's Daughters/Eastern Virginia Medical School|
|Norfolk, Virginia, United States, 23510|
|Study Director:||Alan S Ryan, PhD||Martek Biosciences Corporation|