| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN87269559 |
| Date ISRCTN assigned | 12/09/2003 |
| Local reference number(s) | N0064109021 |
| Public title | Zinc sulphate enema for the management of non-infectious mild to moderate distal colitis |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Digestive System: Colitis |
| Study hypothesis | 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. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 60 Patients. |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 01/04/2002 |
| Anticipated end date | 01/04/2003 |
| Status of trial | Completed |
| Target number of participants | 60 |
| Interventions | 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.
|
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Sandwell and West Birmingham Hospitals NHS Trust - City Hospital |
| Sponsor name | Record provided by the NHS Trusts Clinical Trials Register - Department of Health (UK) |
| Sponsor details | The Department of Health
Richmond House
79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor fax | +44 (0)20 7307 2623 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.doh.gov.uk |
| Contact name | Mr AM El-Tawil |
| Contact details | Department of Gastroenterology
City Hospital
Dudley Road
Birmingham
United Kingdom
B18 7QH |
| Contact telephone | +44 0121 554 3801 |
| Contact fax | +44 |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN87269559 |
| Date last extracted from ISRCTN register | 17/04/2008 |
