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ISRCTN
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ISRCTN16343749
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ClinicalTrials.gov identifier
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Public title
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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.
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0016148139
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Study hypothesis
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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?
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Chronic obstructive pulmonary disease (COPD)
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Participants - inclusion criteria
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Out patients from COPD clinic at the Hammersmith Hospitals NHS Trust
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Participants - exclusion criteria
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Does not meet inclusion criteria
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Anticipated start date
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01/07/2002
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Anticipated end date
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01/07/2003
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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Not provided at time of registration
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Interventions
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Randomised controlled trial
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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1. Hammersmith Hospital NHS Trust (UK)
2. Hammersmith Hospital Trustees Research Committee (HHTRC) (UK)
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Trial website
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Publications
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Contact name
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Dr
Gary
Frost
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Address
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Nutrition & Dietetics Department
2nd Floor, C Block
Hammersmith Hospital
Du Cane Road
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City/town
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London
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Zip/Postcode
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W12 0HS
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Country
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United Kingdom
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Tel
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+44 (0)20 8383 3048(bleep 9027)
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Fax
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+44 (0)20 8383 3379
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Email
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g.frost@imperial.ac.uk
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Sponsor
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Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)
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Address
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The Department of Health
Richmond House
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44 (0)20 7307 2623
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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30/09/2005
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Last edited
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22/09/2009
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Date ISRCTN assigned
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30/09/2005
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