Effects of Omega-3 EPA/DHA for Soldiers at Risk for Mood Disorders
NCT ID: NCT01216982
Last Updated: 2011-03-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
256 participants
INTERVENTIONAL
2010-11-30
2011-06-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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Lovaza, omega-3 fatty acid ethyl ester
Lovaza, omega-3 fatty acid ethyl ester
Three 1g capsules/day for three months; this corresponds to a total of 2520mg EPA+DHA/day
Placebo
one gram corn oil in a soft gelatin capsule
Placebo, visually identical to Lovaza
Three 1g corn oil capsules/day for three months
Interventions
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Lovaza, omega-3 fatty acid ethyl ester
Three 1g capsules/day for three months; this corresponds to a total of 2520mg EPA+DHA/day
Placebo, visually identical to Lovaza
Three 1g corn oil capsules/day for three months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* score on a mood questionnaire
Exclusion Criteria
* are currently taking antidepressant or other medications for psychiatric purposes
* pregnant
* known fish or shellfish allergy
18 Years
55 Years
ALL
Yes
Sponsors
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GlaxoSmithKline
INDUSTRY
United States Department of Defense
FED
Responsible Party
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1st CAB, US ARMY
Principal Investigators
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Daniel T Johnston, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
United States Department of Defense
Locations
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US Military Base
Camp Taji, , Iraq
Countries
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Other Identifiers
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M-10023
Identifier Type: -
Identifier Source: org_study_id
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