The Effects of Feeding Different Levels of Docosahexaenoic Acid to Pre-School Children

Study Overview
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Brief Summary
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This clinical trial will measure Docosahexaenic Acid (DHA) levels in the blood and evaluate the relation to cognitive outcomes.

Official Title
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The Effects of Feeding Different Levels of Docosahexaenoic Acid to Pre-School Children

Conditions
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Measurement of Docosahexaenoic Acid Levels in Pre-school Children

Intervention / Treatment
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* Other: Milk-based beverage without DHA
* Other: Milk-based beverage with DHA at mid level
* Other: Milk-based beverage with DHA at high level


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Milk-based beverage with DHA at mid-level<br> | Other: Milk-based beverage with DHA at mid level<br> <br> |
| Experimental: Milk-based beverage with DHA at high level<br> | Other: Milk-based beverage with DHA at high level<br> <br> |
| Active Comparator: Milk-based beverage without DHA<br> | Other: Milk-based beverage without DHA<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatty Acid Desaturase (FADS) genotypes |  | Once | 
| Plasma Vitamin D levels |  | 6 months | 
| Iron levels in the blood |  | 6 months | 
| Blood Pressure |  | 6 months | 
| Heart Rate |  | 6 months | 
| Height and Weight |  | 6 months | 
| 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 |