Condition category
Digestive System
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
15/11/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr AM El-Tawil

ORCID ID

Contact details

Department of Gastroenterology
City Hospital
Dudley Road
Birmingham
B18 7QH
United Kingdom
+44 (0)121 554 3801

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0064109021

Study information

Scientific title

Acronym

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.

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

Not specified

Trial type

Treatment

Patient information sheet

Condition

Colitis

Intervention

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.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/04/2002

Overall trial end date

01/04/2003

Reason abandoned

Eligibility

Participant inclusion criteria

60 patients.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

60

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/04/2002

Recruitment end date

01/04/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Gastroenterology
Birmingham
B18 7QH
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

Sandwell and West Birmingham Hospitals NHS Trust - City Hospital (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

Publication citations

Additional files

Editorial Notes