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
Funders
Funder type
Research council
Funder name
Medical Research Council (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
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