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

Completed · Phase 3 · Has a placebo group

Conditions studied: Healthy

In brief

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.

Key facts

Study ID: NCT00351624
Run by: dsm-firmenich Switzerland AG
People needed: 216
Starts: 2006-05-01
Expected to finish: 2007-09-01
Last updated by the study team: 2014-05-20

Who can join

Age: 4 and older, up to 4. Sex: any. Healthy volunteers: accepted.

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 A subject will not be withdrawn from the trial if he/she needs to take one of these medications after enrollment.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)

Where it is running

Impact Clinical Trials — Los Angeles, California, United States
Clinical Research Atlanta — Stockbridge, Georgia, United States
Northern Illinois Research Associates — DeKalb, Illinois, United States
Pedia Research — Owensboro, Kentucky, United States
Clinical Research Center of Nevada — Las Vegas, Nevada, United States
Eminence Research, LLC — Oklahoma City, Oklahoma, United States
Prevention and Strengthening Solutions, Inc. — Humboldt, Tennessee, United States
Southwest Children's Research Associates — San Antonio, Texas, United States
Charlottesville Medical Research — Charlottesville, Virginia, United States
Children's Hospital of the King's Daughters/Eastern Virginia Medical School — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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