Condition category
Respiratory
Date applied
14/10/2005
Date assigned
21/10/2005
Last edited
18/10/2010
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Stephen Howie

ORCID ID

Contact details

MRC Laboratories
P.O. Box 273
Banjul
000 000
Gambia
+220 4494438
showie@mrc.gm

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

SCC967

Study information

Scientific title

Acronym

Study hypothesis

Zinc supplementation given to Gambian children as an adjunct therapy in severe or very severe pneumonia will be associated with more rapid recovery.

Ethics approval

Added as of 14/09/2007: The trial was approved by the Gambia Government/MRC Laboratories Joint Ethics Committee on 5 October 2005. (ref: SCC967)

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

Severe and very severe pneumonia defined clinically

Intervention

Interventions amended as of 17/09/2007:

Zinc sulphate or placebo. Zinc will be given once daily orally at a dose of 10 mg in those aged 2-11 months and 20 mg in those 12-59 months. All participants will receive zinc or placebo for 7 days, while a randomly selected subgroup will receive 6 months supplementation.

Please note that this amendment reflects an error in the information provided at time of registration and not a change in protocol; zinc sulphate has been used throughout the trial.

Interventions provided at time of registration:

Zinc acetate or placebo. Zinc will be given once daily orally at a dose of 10 mg in those aged 2-11 months and 20 mg in those 12-59 months. All participants will receive zinc or placebo for 7 days, while a randomly selected subgroup will receive 6 months supplementation.

Intervention type

Supplement

Phase

Not Specified

Drug names

Zinc supplementation

Primary outcome measures

Treatment failure at 5 days

Secondary outcome measures

The following will be assessed after 6 months supplementation of zinc or placebo in a subgroup:
1. Time to resolution of signs of severe and very severe pneumonia
2. Length of admission
3. Height
4. Multi-antigen skin testing

Overall trial start date

24/10/2005

Overall trial end date

31/03/2011

Reason abandoned

Eligibility

Participant inclusion criteria

Prior to 18/10/10:
Children aged 2-59 months presenting with severe or very severe pneumonia to the MRC Hospital or the Royal Victoria Teaching Hospital, Banjul.

Modified on 18/10/10:
'Children aged 2-59 months presenting with severe or very severe pneumonia to the MRC Hospital, the Royal Victoria Teaching Hospital, Banjul, and the health centres at Fajikunda, Brikama, Serekunda and Basse.

Participant type

Patient

Age group

Child

Gender

Not Specified

Target number of participants

600

Participant exclusion criteria

Children with severe malnutrition or signs of systemic infection other than pneumonia

Recruitment start date

24/10/2005

Recruitment end date

31/03/2011

Locations

Countries of recruitment

Gambia

Trial participating centre

MRC Laboratories
Banjul
000 000
Gambia

Sponsor information

Organisation

Medical Research Council (UK)

Sponsor details

20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
corporate@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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