Zinc sulphate enema for the management of non-infectious mild to moderate distal colitis

ISRCTN	ISRCTN87269559
DOI	https://doi.org/10.1186/ISRCTN87269559
Secondary identifying numbers	N0064109021

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Mr AM El-Tawil
Scientific

Department of Gastroenterology
City Hospital
Dudley Road
Birmingham
B18 7QH
United Kingdom

Phone	+44 (0)121 554 3801

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/04/2002
Completion date	01/04/2003

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	60
Key inclusion criteria	60 patients.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/04/2002
Date of final enrolment	01/04/2003

Department of Gastroenterology

Birmingham
B18 7QH
United Kingdom

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.doh.gov.uk

Government

Sandwell and West Birmingham Hospitals NHS Trust - City Hospital (UK)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan