Condition category
Respiratory
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
01/03/2016
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 Gary Frost

ORCID ID

Contact details

Nutrition & Dietetics Department
2nd Floor
C Block
Hammersmith Hospital
Du Cane Road
London
W12 0HS
United Kingdom
+44 (0)20 8383 3048(bleep 9027)
g.frost@imperial.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0016148139

Study information

Scientific title

Pilot study to investigate dietary supplementation of elderly COPD patients with an oral nutritional supplement enriched with n-3 polyunsaturated fatty acids and its effect on respiratory function, appetite and weight

Acronym

Study hypothesis

Does the addition of fish oil to a complete nutritional supplement make supplementation more effective? i.e. do patients gain more weight, improve their lung function and exercise tolerance and report improved appetite when compared to patients using supplements without fish oils?

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

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Chronic obstructive pulmonary disease (COPD)

Intervention

Randomised controlled trial

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Improved lung function
2. Decreased sytokine responses.
Fish oils have been used with promising results in other wasting conditions such as HIV, cancer and sepsis. There are no published trials investigating the possible benefits of fish oil supplementation in COPD patients and this proposal aims to do this.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/07/2002

Overall trial end date

01/07/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Out patients from COPD clinic at the Hammersmith Hospitals NHS Trust

Participant type

Patient

Age group

Senior

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/07/2002

Recruitment end date

01/07/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Nutrition & Dietetics Department
London
W12 0HS
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

Government

Funder name

Hammersmith Hospital NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Hammersmith Hospital Trustees Research Committee (HHTRC) (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

01/03/2016: No publications found, verifying study status with principal investigator.