Condition category
Mental and Behavioural Disorders
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
13/10/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Janet Carter

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0577150953

Study information

Scientific title

A randomised placebo-controlled trial of polyunsaturated omega-3 fatty acid (PFA), in the treatment of dementia: a pilot study

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Dementia

Intervention

Randomised double blind placebo-controlled trial

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/09/2004

Overall trial end date

31/03/2005

Reason abandoned

Eligibility

Participant inclusion criteria

50 outpatient attendees at a Memory Clinic with a diagnosis of dementia (MMSE score 17-24).

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

50

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

01/09/2004

Recruitment end date

31/03/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

Funder name

North East London Mental Health NHS Trust (NELMHT), Research & Development Department (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes