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ISRCTN
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ISRCTN65375365
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ClinicalTrials.gov identifier
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Public title
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A multicentre international randomised trial to evaluate percutaneous endoscopic gastrostomy (PEG) and nasogastric (NG) tube feeding in patients admitted to hospital with a recent stroke
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Scientific title
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Acronym
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FOOD
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Serial number at source
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HTA 96/29/01
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Study hypothesis
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FOOD is an international, randomised trial involving a total of at least 4,000 patients which aims to address the following issues: 1) in stroke patients who cannot swallow; does feeding via a Percutaneous Endoscopic Gastrostomy (PEG) tube improve survival free of severe disability compared with that via a Nasal gastric (NG) tube? (500 patients in each arm) 2) In patients who cannot swallow within the first week of admission is immediate initiation of feeding via either a PEG or NG tube (rather than simply hydrating the patient to see if dysphagia will rapidly resolve) associated with improved outcomes? (500 patients in each arm). We will assess the impact of particular feeding regimes on lower complication rates, mortality, improved quality of life amongst survivors and resources use. Using the same trial infrastructure we will also address a third related question: In patients who can swallow, does routine addition of oral nutritional supplements to the normal hospital diet improve patients' outcomes? (1000 patients in each arm). No additional resources are requested to address this third question. We believe that the inclusion of a trial addressing this last question will facilitate the more rapid completion of the tube feeding arms.
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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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International
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Disease/condition/study domain
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Stroke
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Participants - inclusion criteria
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Any patient admitted to hospital with a stroke (excluding those with subarachnoid haemorrhage) within a week of onset, in whom the randomising clinician is substantially uncertain about the best feeding policy.
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Participants - exclusion criteria
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Not provided at time of registration.
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Anticipated start date
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01/02/1999
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Anticipated end date
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31/12/2004
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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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4023
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Interventions
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Please note that, as of 16 January 2008, the start and end date of this trail have been updated from 1 November 1996 and 31 July 2003 to 1 February 1999 and 31 December 2004, respectively.
Interventions:
Trial 1: Normal hospital diet versus Normal hospital diet plus oral supplements (comprising 120 ml containing 1.5 kcal/ml three times a day)
Trial 2: Immediate tube feeding (NG or PEG) versus Delay tube feeding for at least a week and hydrate using parenteral fluids
Trial 3: NG versus PEG
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Primary outcome measure(s)
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Survival without disability, mortality
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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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NIHR Health Technology Assessment Programme - HTA (UK)
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Trial website
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http://www.dcn.ed.ac.uk/food/
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Publications
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http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15733717&query_hl=14&itool=pubmed_docsum
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Contact name
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Dr
MS
Dennis
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Address
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FOOD Trial Co-ordinating Centre
Neurosciences Trials Unit
Western General Hospital
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City/town
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Edinburgh
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Zip/Postcode
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EH4 2XU
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Country
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United Kingdom
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Tel
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+44 (0)131 5372939
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Fax
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+44 (0)131 332 5150
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Email
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MSD@skull.dcn.ed.ac.uk
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Sponsor
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Department of Health (UK)
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Address
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Quarry House
Quarry Hill
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City/town
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Leeds
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Zip/Postcode
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LS2 7UE
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Country
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United Kingdom
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Email
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Sheila.Greener@doh.gsi.gov.uk
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Sponsor website:
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http://www.dh.gov.uk/en/index.htm
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Date applied
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20/03/2002
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Last edited
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16/01/2008
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Date ISRCTN assigned
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20/03/2002
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