A Phase 3 interventional study of DHA and placebo in Healthy, sponsored by DSM Nutritional Products, Inc.. Completed at 10 sites in United States. Open to participants aged 4 Years to 4 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-05-20.
Sponsored by DSM Nutritional Products, Inc. · Phase 3, Interventional, and Treatment
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.
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.
DSM Nutritional Products, Inc. is the lead sponsor of 37 studies on the registry; none are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Behavioral: DHA
Behavioral: placebo
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
This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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DSM Nutritional Products, Inc.