Dietary Supplement for the Prevention of Cognitive Decline in a Very Elderly Population.
Field Trial With Omega-3 Fatty Acid Supplementation for the Prevention of Cognitive Decline in a Very Elderly Population
1 other identifier
interventional
170
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2012
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 20, 2013
CompletedFirst Posted
Study publicly available on registry
March 22, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedJuly 17, 2015
January 1, 2013
3.8 years
March 20, 2013
July 16, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Mini Mental State Examination
MMSE is a brief questionnaire test that is used to screen for cognitive impairment. A validated test in Spanish will be used: Lobo A. Saza P. Marcos G, Díaz J, De la Cámara C, Ventura T et al: Revalidación y normalización del Mini-Examen Cogniscitivo (primera versión en castellano del Mini-Mental Status Examination) en la población general geriátrica. Med Clin (Barc) 1999;112:767-774.
Six months / one year
Secondary Outcomes (3)
Short Portable Mental Status Questionnaire (SPMSQ)
One year
Verbal fluency test
One year
Clock-drawing test
One year
Study Arms (2)
Dietary Supplement capsule
ACTIVE COMPARATOROne capsule at meals (3 each day) during 1 year with Omega-3 fatty acid supplementation
Empty gelatine capsule
PLACEBO COMPARATOROne capsule at meals (3 each day during 1 year)
Interventions
Gelatine capsule, 1 at each meals (3 per day) during one year
Eligibility Criteria
You may qualify if:
- Elderly people aged 75 years or older
- Global Deterioration Scale \< 4
- Capacity to complete the tests
You may not qualify if:
- Neurological, physical or psychiatry conditions, obtained from the medical history, that may have an influence on the cognitive function.
- Dementia
- History of epilepsy, convulsions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Amma Argaray
Pamplona, Navarre, Spain
AMMA Mutilva
Pamplona, Navarre, Spain
AMMA Oblatas
Pamplona, Navarre, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joaquin Baleztena, MD
Clinica Universidad de Navarra
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 20, 2013
First Posted
March 22, 2013
Study Start
January 1, 2012
Primary Completion
October 1, 2015
Study Completion
December 1, 2015
Last Updated
July 17, 2015
Record last verified: 2013-01