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ISRCTN
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ISRCTN87269559
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ClinicalTrials.gov identifier
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Public title
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Zinc sulphate enema for the management of non-infectious mild to moderate distal colitis
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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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N0064109021
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Study hypothesis
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To examine the effect of zinc sulphate solution enema on patients with mild to moderate distal colitis. Although it is appreciated that Crohn's disease and ulcerative colitis result in malabsorption of a variety of nutrients and that hypozincemia may occur in patients with Crohn's disease or ulcerative colitis, relatively little investigation has been directed toward the sequel of zinc deficiency in this disorder. We assume that zinc has an anti-inflammatory power. If this approach proves effective then it is likely to alleviate much suffering.
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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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Digestive System: Colitis
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Participants - inclusion criteria
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60 Patients.
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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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01/04/2002
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Anticipated end date
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01/04/2003
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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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60
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Interventions
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Single centre, patient volunteers, prospective, controlled, therapeutic, observational, double-blind, placebo, drugs, invasive procedures, randomised.
FUNDING NOT SECURED AND TRIAL NOT STARTED AS OF APRIL 2005.
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Primary outcome measure(s)
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Not provided at time of registration
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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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Sandwell and West Birmingham Hospitals NHS Trust - City Hospital
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Trial website
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Publications
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Contact name
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Mr
AM
El-Tawil
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Address
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Department of Gastroenterology
City Hospital
Dudley Road
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City/town
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Birmingham
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Zip/Postcode
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B18 7QH
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Country
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United Kingdom
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Tel
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+44 0121 554 3801
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Fax
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+44
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Email
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Sponsor
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Record provided by the NHS Trusts Clinical Trials Register - 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.doh.gov.uk
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Date applied
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12/09/2003
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Last edited
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21/11/2005
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Date ISRCTN assigned
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12/09/2003
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