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Non-compliance
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| Name | Class |
|---|---|
| University of Kansas | OTHER |
| John Colombo, PhD, The University of Kansas | UNKNOWN |
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This clinical trial will measure Docosahexaenic Acid (DHA) levels in the blood and evaluate the relation to cognitive outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Milk-based beverage with DHA at mid-level | Experimental |
| |
| Milk-based beverage with DHA at high level | Experimental |
| |
| Milk-based beverage without DHA | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Milk-based beverage without DHA | Other |
| ||
| Milk-based beverage with DHA at mid level |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Fatty Acid Desaturase (FADS) genotypes | Once | |
| Plasma Vitamin D levels | 6 months | |
| Iron levels in the blood |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carol Lynn Berseth, M.D. | Mead Johnson Nutrition | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universty of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
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| Other |
|
| Milk-based beverage with DHA at high level | Other |
|
| 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 |