A randomised placebo-controlled trial of polyunsaturated omega-3 fatty acid (PFA), in the treatment of dementia: a pilot study
ISRCTN | ISRCTN27372325 |
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DOI | https://doi.org/10.1186/ISRCTN27372325 |
Secondary identifying numbers | N0577150953 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 02/02/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Janet Carter
Scientific
Scientific
North East London Mental Health Trust
Mascalls Park
Mascalls Lane
Brentwood
CM14 5HQ
United Kingdom
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
Scientific title | A randomised placebo-controlled trial of polyunsaturated omega-3 fatty acid (PFA), in the treatment of dementia: a pilot study |
Study objectives | A pilot study to evaluate the conjunctive, functional and behavioural effects of dietary supplementation of omega-3 PFA in elderly patients with dementia. |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Dementia |
Intervention | Randomised double-blind placebo-controlled trial |
Intervention type | Supplement |
Primary outcome measure | Improvements in mood, cognition, quality of life on the functioning measures MMSE, QOL-AD, GHQ-12, CIBIC and neuropsychological battery subjects. |
Secondary outcome measures | Not provided at time of registration |
Overall study start date | 01/09/2004 |
Completion date | 31/03/2005 |
Eligibility
Participant type(s) | Patient |
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Age group | Senior |
Sex | Both |
Target number of participants | 50 |
Key inclusion criteria | 50 outpatient attendees at a Memory Clinic with a diagnosis of dementia (MMSE score 17-24) |
Key exclusion criteria | Does not meet inclusion criteria |
Date of first enrolment | 01/09/2004 |
Date of final enrolment | 31/03/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
North East London Mental Health Trust
Brentwood
CM14 5HQ
United Kingdom
CM14 5HQ
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Phone | +44 (0)20 7307 2622 |
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dhmail@doh.gsi.org.uk | |
Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Hospital/treatment centre
North East London Mental Health NHS Trust (NELMHT), Research & Development Department (UK)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Editorial Notes
02/02/2018: No publications found, verifying study status with principal investigator.