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

NCT01216982 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 256

Last updated 2011-03-09

No results posted yet for this study

Summary

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.

Conditions

  • Mood Disorders
  • Depression
  • Combat Disorders
  • Stress Disorders

Interventions

DRUG

Lovaza, omega-3 fatty acid ethyl ester

Three 1g capsules/day for three months; this corresponds to a total of 2520mg EPA+DHA/day

DRUG

Placebo, visually identical to Lovaza

Three 1g corn oil capsules/day for three months

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • United States Department of Defense

    lead FED

Principal Investigators

  • Daniel T Johnston, MD, MPH · United States Department of Defense

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2011-02-28
Completion
2011-06-30

Countries

  • Iraq

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01216982 on ClinicalTrials.gov