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

This study has been completed.
Sponsor:
Information provided by:
DSM Nutritional Products, Inc.
ClinicalTrials.gov Identifier:
NCT00351624
First received: July 11, 2006
Last updated: May 16, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Healthy
Behavioral: DHA
Behavioral: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of DHA on Cognitive Functions in Preschool Children

Resource links provided by NLM:


Further study details as provided by DSM Nutritional Products, Inc.:

Primary Outcome Measures:
  • Leiter Test of Sustained Attention
  • Kiddie Continuous Performance Test (kCAP)
  • Peabody Picture Vocabulary Test
  • Day-Night Stroop Test

Secondary Outcome Measures:
  • Safety and tolerability of the DHA dose
  • Blood DHA levels before and after DHA supplementation

Enrollment: 216
Study Start Date: May 2006
Study Completion Date: September 2007
Arms Assigned Interventions
Active Comparator: DHA Behavioral: DHA
Placebo Comparator: placebo Behavioral: placebo

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

Ages Eligible for Study:   4 Years to 4 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00351624

Locations
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
Pedia Research
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
Sponsors and Collaborators
DSM Nutritional Products, Inc.
Investigators
Study Director: Alan S Ryan, PhD DSM Nutritional Products, Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00351624     History of Changes
Other Study ID Numbers: Martek #2006-1008
Study First Received: July 11, 2006
Last Updated: May 16, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by DSM Nutritional Products, Inc.:
DHA supplementation
Cognitive function
Preschool children
Attention and behavior
Healthy Children

ClinicalTrials.gov processed this record on August 28, 2014