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

ISRCTN ISRCTN16343749
DOI https://doi.org/10.1186/ISRCTN16343749
Secondary identifying numbers N0016148139
Submission date
30/09/2005
Registration date
30/09/2005
Last edited
10/05/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Respiratory
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 Gary Frost
Scientific

Nutrition & Dietetics Department
2nd Floor, C Block
Hammersmith Hospital
Du Cane Road
London
W12 0HS
United Kingdom

Phone +44 (0)20 8383 3048(bleep 9027)
Email g.frost@imperial.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titlePilot 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
Study objectivesDoes 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedChronic obstructive pulmonary disease (COPD)
InterventionRandomised controlled trial
Intervention typeOther
Primary outcome measure1. 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 measuresNot provided at time of registration
Overall study start date01/07/2002
Completion date01/07/2003

Eligibility

Participant type(s)Patient
Age groupSenior
SexNot Specified
Target number of participantsNot provided at time of registration
Key inclusion criteriaOut patients from COPD clinic at the Hammersmith Hospitals NHS Trust
Key exclusion criteriaDoes not meet inclusion criteria
Date of first enrolment01/07/2002
Date of final enrolment01/07/2003

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Nutrition & Dietetics Department
London
W12 0HS
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

Government

Hammersmith Hospital NHS Trust (UK)

No information available

Hammersmith Hospital Trustees Research Committee (HHTRC) (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

10/05/2018: No publications found, verifying study status with principal investigator.
01/03/2016: No publications found, verifying study status with principal investigator.