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
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

North East London Mental Health Trust
Mascalls Park
Mascalls Lane
Brentwood
CM14 5HQ
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleA randomised placebo-controlled trial of polyunsaturated omega-3 fatty acid (PFA), in the treatment of dementia: a pilot study
Study objectivesA 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) studiedDementia
InterventionRandomised double-blind placebo-controlled trial
Intervention typeSupplement
Primary outcome measureImprovements in mood, cognition, quality of life on the functioning measures MMSE, QOL-AD, GHQ-12, CIBIC and neuropsychological battery subjects.
Secondary outcome measuresNot provided at time of registration
Overall study start date01/09/2004
Completion date31/03/2005

Eligibility

Participant type(s)Patient
Age groupSenior
SexBoth
Target number of participants50
Key inclusion criteria50 outpatient attendees at a Memory Clinic with a diagnosis of dementia (MMSE score 17-24)
Key exclusion criteriaDoes not meet inclusion criteria
Date of first enrolment01/09/2004
Date of final enrolment31/03/2005

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

North East London Mental Health Trust
Brentwood
CM14 5HQ
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

02/02/2018: No publications found, verifying study status with principal investigator.