Ignite Creation Date:
2024-05-05 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00351624
Status:
COMPLETED
Last Update Posted:
2014-05-20
First Post:
2006-07-11
Brief Title:
Effects of Docosahexaenoic Acid DHA on Cognitive Function in Children 4 Years of Age
Sponsor:
DSM Nutritional Products Inc
Organization:
DSM Nutritional Products Inc
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Study to Evaluate the Effects of DHA on Cognitive Functions in Preschool Children
Status:
COMPLETED
Status Verified Date:
2014-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this study is to determine whether a 4-month period of supplementation with 400 mgday 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
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
Detailed Description:
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 eg 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-deficithyperactivity 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
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-deficithyperactivity 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None