Status:
COMPLETED
Effects of Docosahexaenoic Acid (DHA) on Cognitive Function in Children 4 Years of Age
Lead Sponsor:
DSM Nutritional Products, Inc.
Conditions:
Healthy
Eligibility:
All Genders
4-4 years
Phase:
PHASE3
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 bubbleg...
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, ...
Eligibility Criteria
Inclusion
- 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 A subject will not be withdrawn from the trial if he/she needs to take one of these medications after enrollment.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
- 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)
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
216 Patients enrolled
Trial Details
Trial ID
NCT00351624
Start Date
May 1 2006
End Date
September 1 2007
Last Update
May 20 2014
Active Locations (10)
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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