A randomised placebo-controlled trial of polyunsaturated omega-3 fatty acid (PFA), in the treatment of dementia: a pilot study
| ISRCTN | ISRCTN27372325 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27372325 |
| Protocol serial number | N0577150953 |
| Sponsor | Department of Health |
| Funder | North East London Mental Health NHS Trust (NELMHT), Research & Development Department (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
Improvements in mood, cognition, quality of life on the functioning measures MMSE, QOL-AD, GHQ-12, CIBIC and neuropsychological battery subjects. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/03/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
North East London Mental Health Trust
Brentwood
CM14 5HQ
United Kingdom
CM14 5HQ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
02/02/2018: No publications found, verifying study status with principal investigator.
