Status:
TERMINATED
The Effects of Feeding Different Levels of Docosahexaenoic Acid to Pre-School Children
Lead Sponsor:
Mead Johnson Nutrition
Collaborating Sponsors:
University of Kansas
John Colombo, PhD, The University of Kansas
Conditions:
Measurement of Docosahexaenoic Acid Levels in Pre-school Children
Eligibility:
All Genders
3-3 years
Phase:
NA
Brief Summary
This clinical trial will measure Docosahexaenic Acid (DHA) levels in the blood and evaluate the relation to cognitive outcomes.
Eligibility Criteria
Inclusion
- Child is 3 years of age ± 90 days
- Weight for length is within 10th to 90th percentile as plotted on WHO growth charts
- Parent/caregiver reports that child consumes at least 6 oz of cow milk or cow milk-based beverages on a daily basis
- Parent is willing to exclude sources of DHA from child's diet during the study
- Parent agrees not to give vitamins to child during the study
- English is the primary language in the home
- Signed Informed Consent and Protected Health Information
Exclusion
- Gestational age at birth ≤ 36 weeks
- History of neuro/psychiatric conditions
- History of underlying metabolic or chronic disease
- Child is ill, has used antihistamines or diagnosed with an infection at time of cognitive testing
- History of suspected or known cow milk protein intolerance
- Child's diet contains sources of supplemental DHA more than one time per week
- Child is from a multiple birth and the sibling(s) are living in the same household
- Child is enrolled in another interventional clinical research study
- Use of antihistamines within 12 hours of cognitive testing
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01897948
Start Date
July 1 2013
End Date
March 1 2014
Last Update
April 7 2014
Active Locations (1)
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1
Universty of Kansas Medical Center
Kansas City, Kansas, United States, 66160