Clinical trial NCT00351624: Effects of Docosahexaenoic Acid (DHA) on Cognitive Function in Children 4 Years of Age
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of DHA on Cognitive Functions in Preschool Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy
Keywords: DHA supplementation
Cognitive function
Preschool children
Attention and behavior
Healthy Children
Lead sponsor: DSM Nutritional Products, Inc.
Sponsor class: INDUSTRY
First posted: 2006-07-13
Enrollment: 216
Sex: ALL
Minimum age (years): 4
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 (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.

Eligibility criteria: Inclusion Criteria:

* Male or female, age at enrollment between 4 years 0 months and 4 years 8 months
* Height and weight between the 10th and 90th percentiles of the National Center for Health Statistics (NCHS) growth charts
* Subject must meet normal developmental milestones.
* Subject able to understand instructions provided during the cognitive testing, i.e. English must be the primary language in the home
* No evidence of a medical condition that would preclude successful response or outcome (e.g., uncorrected vision or hearing impairment, attention deficit disorder, or inborn error of metabolism)
* Not taking any medications for seizure disorder, anxiety disorders (e.g., Valium or related compounds), ADHD (e.g., Ritalin, Adderall, Concerta, Strattera, or similar medication), childhood psychosis (e.g., Haldol, Risperdal), depression (e.g., Prozac), or for bipolar disorder. A subject will not be withdrawn from the trial if he/she needs to take one of these medications after enrollment. Antihistamines (e.g., Benadryl or other antihistamines) should not be administered within 24 hours of the day of the cognitive exams (Claritin or Allegra are allowed). If a subject is taking an antihistamine on the day of the cognitive tests, the tests will be rescheduled.

Exclusion Criteria:

* Premature birth (\< 36 weeks gestation)
* Family history of ADHD
* Subject consumes \> 3 oz. of fish more than 2 times per week.
* Subject consumes dietary supplements or foods containing or fortified with omega-3 fatty acids.
* Subject received any investigational product within the past 30 days.
* Subject having any medical condition that in the opinion of the principal investigator would preclude a successful response or outcome (e.g., uncorrected vision or hearing impairment, attention deficit disorder or inborn error of metabolism)

Primary outcomes:
measure: Leiter Test of Sustained Attention
measure: Kiddie Continuous Performance Test (kCAP)
measure: Peabody Picture Vocabulary Test
measure: Day-Night Stroop Test
Secondary outcomes:
measure: Safety and tolerability of the DHA dose
measure: Blood DHA levels before and after DHA supplementation
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Impact Clinical Trials
state: California
city: Stockbridge
country: United States
facility: Clinical Research Atlanta
state: Georgia
city: Dekalb
country: United States
facility: Northern Illinois Research Associates
state: Illinois
city: Owensboro
country: United States
facility: Pedia Research
state: Kentucky
city: Las Vegas
country: United States
facility: Clinical Research Center of Nevada
state: Nevada
city: Oklahoma City
country: United States
facility: Eminence Research, LLC
state: Oklahoma
city: Humboldt
country: United States
facility: Prevention and Strengthening Solutions, Inc.
state: Tennessee
city: San Antonio
country: United States
facility: Southwest Children's Research Associates
state: Texas
city: Charlottesville
country: United States
facility: Charlottesville Medical Research
state: Virginia
city: Norfolk
country: United States
facility: Children's Hospital of the King's Daughters/Eastern Virginia Medical School
state: Virginia
Study officials:
affiliation: DSM Nutritional Products, Inc.
name: Alan S Ryan, PhD
role: STUDY_DIRECTOR
References: