Effects of Docosahexaenoic Acid (DHA) on Cognitive Function in Children 4 Years of Age

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of DHA on Cognitive Functions in Preschool Children

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 Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Behavioral: placebo; Behavioral: DHA

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.

• Study Type: Interventional
• Enrollment (Actual): 216
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90010
      • Impact Clinical Trials
  • Georgia
    • Stockbridge, Georgia, United States, 30281
      • Clinical Research Atlanta
  • Illinois
    • Dekalb, Illinois, United States, 60135
      • Northern Illinois Research Associates
  • Kentucky
    • Owensboro, Kentucky, United States, 42301
      • Pedia Research
  • Nevada
    • Las Vegas, Nevada, United States, 89104
      • Clinical Research Center of Nevada
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73118
      • Eminence Research, LLC
  • Tennessee
    • Humboldt, Tennessee, United States, 38343
      • Prevention and Strengthening Solutions, Inc.
  • Texas
    • San Antonio, Texas, United States, 78229
      • Southwest Children's Research Associates
  • Virginia
    • Charlottesville, Virginia, United States, 22911
      • Charlottesville Medical Research
    • Norfolk, Virginia, United States, 23510
      • Children's Hospital of the King's Daughters/Eastern Virginia Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 4 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo	Behavioral: placebo
Active Comparator: DHA	Behavioral: DHA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Leiter Test of Sustained Attention
Kiddie Continuous Performance Test (kCAP)
Peabody Picture Vocabulary Test
Day-Night Stroop Test

Secondary Outcome Measures

Outcome Measure
Safety and tolerability of the DHA dose
Blood DHA levels before and after DHA supplementation

Collaborators and Investigators

• Sponsor: DSM Nutritional Products, Inc.
• Investigators: Study Director: Alan S Ryan, PhD, DSM Nutritional Products, Inc.

Study record dates

Study Major Dates

• Study Start: May 1, 2006
• Study Completion (Actual): September 1, 2007

Study Registration Dates

• First Submitted: July 11, 2006
• First Submitted That Met QC Criteria: July 11, 2006
• First Posted (Estimate): July 13, 2006

Study Record Updates

• Last Update Posted (Estimate): May 20, 2014
• Last Update Submitted That Met QC Criteria: May 16, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: Cognitive function; Preschool children; Healthy Children; DHA supplementation; Attention and behavior
• Other Study ID Numbers: Martek #2006-1008