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 20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
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