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

Sponsor

DSM Nutritional Products, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00351624

Collaborator

(none)

216

Enrollment

Locations

Arms

Duration (Months)

21.6

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Behavioral: DHA Behavioral: placebo	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

216 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2006

Actual Study Completion Date :

Sep 1, 2007

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: DHA

Behavioral: DHA

Placebo Comparator: placebo

Behavioral: placebo

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 4 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

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