Measurement of Docosahexaenoic Acid Levels in Pre-school Children
Conditions
Brief summary
This clinical trial will measure Docosahexaenic Acid (DHA) levels in the blood and evaluate the relation to cognitive outcomes.
Interventions
OTHERMilk-based beverage without DHA
OTHERMilk-based beverage with DHA at mid level
OTHERMilk-based beverage with DHA at high level
Sponsors
University of Kansas
John Colombo, PhD, The University of Kansas
Mead Johnson Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
3 Years to 3 Years
Healthy volunteers
Yes
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Red Blood Cell phospholipid weight percent of Docosahexaenoic Acid | 6 months |
| Cognitive Measures - Executive Function, Language Development, and Behavior Assessment | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Iron levels in the blood | 6 months |
| Blood Pressure | 6 months |
| Heart Rate | 6 months |
| Fatty Acid Desaturase (FADS) genotypes | Once |
| Recall of dietary intake at each study visit | 6 months |
| Parental Product Assessment Questionnaire completed at Study Visit 2 | once |
| Medically-confirmed adverse events collected throughout the study period | 6 months |
| Height and Weight | 6 months |
| Plasma Vitamin D levels | 6 months |
Countries
United States
Outcome results
None listed