NCT00351624

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
216

participants targeted

Target at P50-P75 for phase_3 healthy

Timeline
Completed

Started May 2006

Typical duration for phase_3 healthy

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 13, 2006

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

May 20, 2014

Status Verified

May 1, 2014

First QC Date

July 11, 2006

Last Update Submit

May 16, 2014

Conditions

Healthy

Keywords

DHA supplementationCognitive functionPreschool childrenAttention and behaviorHealthy Children

Outcome Measures

Primary Outcomes (4)

  • Leiter Test of Sustained Attention

  • Kiddie Continuous Performance Test (kCAP)

  • Peabody Picture Vocabulary Test

  • Day-Night Stroop Test

Secondary Outcomes (2)

  • Safety and tolerability of the DHA dose

  • Blood DHA levels before and after DHA supplementation

Study Arms (2)

DHA

ACTIVE COMPARATOR
Behavioral: DHA

placebo

PLACEBO COMPARATOR
Behavioral: placebo

Interventions

DHABEHAVIORAL
DHA
placeboBEHAVIORAL
placebo

Eligibility Criteria

Age4 Years - 4 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Impact Clinical Trials

Los Angeles, California, 90010, United States

Location

Clinical Research Atlanta

Stockbridge, Georgia, 30281, United States

Location

Northern Illinois Research Associates

DeKalb, Illinois, 60135, United States

Location

Pedia Research

Owensboro, Kentucky, 42301, United States

Location

Clinical Research Center of Nevada

Las Vegas, Nevada, 89104, United States

Location

Eminence Research, LLC

Oklahoma City, Oklahoma, 73118, United States

Location

Prevention and Strengthening Solutions, Inc.

Humboldt, Tennessee, 38343, United States

Location

Southwest Children's Research Associates

San Antonio, Texas, 78229, United States

Location

Charlottesville Medical Research

Charlottesville, Virginia, 22911, United States

Location

Children's Hospital of the King's Daughters/Eastern Virginia Medical School

Norfolk, Virginia, 23510, United States

Location

MeSH Terms

Conditions

Behavior

Study Officials

  • Alan S Ryan, PhD

    DSM Nutritional Products, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 11, 2006

First Posted

July 13, 2006

Study Start

May 1, 2006

Study Completion

September 1, 2007

Last Updated

May 20, 2014

Record last verified: 2014-05

Locations

US(10)