Effects of Omega-3 EPA/DHA for Soldiers at Risk for Mood Disorders

NCT ID: NCT01216982

Last Updated: 2011-03-09

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

256 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Mood Disorders Depression Combat Disorders Stress Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Lovaza, omega-3 fatty acid ethyl ester

Group Type ACTIVE_COMPARATOR

Lovaza, omega-3 fatty acid ethyl ester

Intervention Type DRUG

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

Group Type PLACEBO_COMPARATOR

Placebo, visually identical to Lovaza

Intervention Type DRUG

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

Intervention Type DRUG

Placebo, visually identical to Lovaza

Three 1g corn oil capsules/day for three months

Intervention Type DRUG

Other Intervention Names

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LOVAZA 1g Soft Gelatin Capsules NDC NO. 65726-425-15 Omega-3-Acid Ethyl Esters Corn oil

Eligibility Criteria

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Inclusion Criteria

* US Army deployed personnel
* score on a mood questionnaire

Exclusion Criteria

* currently consume omega-3 fish oil supplements
* are currently taking antidepressant or other medications for psychiatric purposes
* pregnant
* known fish or shellfish allergy
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

United States Department of Defense

FED

Sponsor Role lead

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

Site Status

Countries

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Iraq

Other Identifiers

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M-10023

Identifier Type: -

Identifier Source: org_study_id

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