Mild Cognitive Impairment Clinical Trial
Official title:
Field Trial With Omega-3 Fatty Acid Supplementation for the Prevention of Cognitive Decline in a Very Elderly Population
The purpose of this study is to determine whether an omega-3 fatty acid supplementation is effective in the prevention of progressive cognitive decline in elderly people aged 75 years or older.
Participants are residents at three nursing homes in Pamplona (Spain). We assumed that 20%
of elderly people have a cognitive decline and we estimated a 5% of cognitive decline in the
intervention group. Sample size estimated was 85 participants for each arm, assuming two
groups with an alpha of 0.05, 80% power and accounting for 10% of participants lost to
follow-up.
Repeated measures ANOVA, Cox regression and multiple linear regression analysis will be used
for the statistical analysis of data.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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