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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
Stress-related disorders are among the most prevalent and expensive medical consequences of participation in military operations. Omega-3 fatty acids EPA/DHA derived from fish oil are known to benefit both neuronal development in the young, and cognition and mood in various populations.
It is possible that soldiers receiving Omega-3 EPA/DHA will exhibit significantly higher cognitive performance, better affect/mood state, and less combat stress symptomatology compared to the placebo after 12 weeks of supplementation. A goal would be to reduce the prevalence of combat stress injuries in military personnel.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lovaza, omega-3 fatty acid ethyl ester | Active Comparator |
| |
| Placebo | Placebo Comparator | one gram corn oil in a soft gelatin capsule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lovaza, omega-3 fatty acid ethyl ester | Drug | Three 1g capsules/day for three months; this corresponds to a total of 2520mg EPA+DHA/day |
|
| Measure | Description | Time Frame |
|---|---|---|
| primary psychometric assessment battery | Specific components include: Zung Depression Scale (ZDS) Zung Anxiety Scale (ZAS) Pittsburgh Sleep Quality Index (PSQI) Epworth Sleepiness Scale (ESS) | 3 months |
| omega-3 fatty acid status | finger-prick blood spot is collected for determination of fatty acid composition and profile. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| secondary psychometric assessment battery | This battery will generate index scores in the area of: Memory, Psychomotor Speed, Reaction Time, Cognitive Flexibility, and Complex Attention. It will also include the Alcohol Use Identification Test (AUdIT). Military-specific components include Post-Deployment Health Assessment (PDHA), Neurobehavioral Symptom Inventory (NSI), Combat Exposure Scale (CES), and parts of the Deployment Risk and Resilience Inventory (edited). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel T Johnston, MD, MPH | United States Department of Defense | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| US Military Base | Camp Taji | 09378 | Iraq |
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| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D003863 | Depression |
| D003130 | Combat Disorders |
| D040921 | Stress Disorders, Traumatic |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D000068099 | Trauma and Stressor Related Disorders |
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| ID | Term |
|---|---|
| C405603 | Omacor |
| D003314 | Corn Oil |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
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|
| Placebo, visually identical to Lovaza | Drug | Three 1g corn oil capsules/day for three months |
|
|
| 3 months |
| D005224 |
| Fats, Unsaturated |
| D010938 | Plant Oils |
| D009821 | Oils |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |