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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01216982
Other study ID # M-10023
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received October 6, 2010
Last updated March 8, 2011
Start date November 2010
Est. completion date June 2011

Study information

Verified date March 2011
Source United States Department of Defense
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 256
Est. completion date June 2011
Est. primary completion date February 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 55 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care


Intervention

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
Placebo, visually identical to Lovaza
Three 1g corn oil capsules/day for three months

Locations

Country Name City State
Iraq US Military Base Camp Taji

Sponsors (2)

Lead Sponsor Collaborator
United States Department of Defense GlaxoSmithKline

Country where clinical trial is conducted

Iraq, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Primary omega-3 fatty acid status finger-prick blood spot is collected for determination of fatty acid composition and profile. 3 months No
Secondary 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).
3 months No
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