Status:
COMPLETED
The Efficacy of Omega-3 Fatty Acids in Maintaining Optimal Mental Health in Elderly People
Lead Sponsor:
ZonMw: The Netherlands Organisation for Health Research and Development
Conditions:
Cognitive Impairment
Depression
Eligibility:
All Genders
65+ years
Phase:
NA
Brief Summary
The efficacy of EPA-DHA supplementation will be assessed in a randomized placebo-controlled trial with cognitive decline and early signs of depression as primary outcome measures.
Detailed Description
The efficacy of EPA-DHA supplementation will be assessed in a randomized placebo-controlled trial with cognitive decline and early signs of depression as primary outcome measures. In this study 300 el...
Eligibility Criteria
Inclusion
- Men and women
- Aged 65 years and over
- Informed consent signed
Exclusion
- A score of \> 16 on the CES-D (Centre for Epidemiological Studies-Depression Scale
- A score of \< 21 points on MMSE (Mini-Mental State Examination)
- Current or recent (\<4 weeks) use of fish oil supplements or intake of more than 4 times fish as judged by a fish consumption questionnaire
- Current use of pharmacological antidepressants
- Current use of dementia (Alzheimer) medication
- Serious liver disease
- Use of more than 4 glasses of alcohol per day
- Unable to participate as judged by the responsible medical physician
- Allergy to fish(oil)
- Swallowing problems
- Participation in another clinical trial less than 2 months before the start of the trial or at the same time
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
302 Patients enrolled
Trial Details
Trial ID
NCT00124852
Start Date
October 1 2005
End Date
July 1 2007
Last Update
January 12 2011
Active Locations (1)
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1
Wageningen University
Wageningen, Gelderland, Netherlands, 6700 EV