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ISRCTN
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ISRCTN33548493
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ClinicalTrials.gov identifier
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Public title
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Efficacy of zinc as an adjunct therapy in the management of severe pneumonia among Gambian children
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Scientific title
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Acronym
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N/A
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Serial number at source
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SCC967
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Study hypothesis
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Zinc supplementation given to Gambian children as an adjunct therapy in severe or very severe pneumonia will be associated with more rapid recovery.
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Lay summary
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Ethics approval
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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)
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Study design
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Randomised controlled trial
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Countries of recruitment
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Gambia
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Disease/condition/study domain
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Severe and very severe pneumonia defined clinically
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Participants - inclusion criteria
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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.
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Participants - exclusion criteria
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Children with severe malnutrition or signs of systemic infection other than pneumonia
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Anticipated start date
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24/10/2005
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Anticipated end date
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31/03/2011
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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600
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Interventions
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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.
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Primary outcome measure(s)
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Treatment failure at 5 days
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Secondary outcome measure(s)
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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
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Sources of funding
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Medical Research Council (UK)
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Trial website
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Publications
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Contact name
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Dr
Stephen
Howie
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Address
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MRC Laboratories
P.O. Box 273
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City/town
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Banjul
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Zip/Postcode
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000 000
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Country
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Gambia
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Tel
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+220 4494438
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Fax
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+220 4494438
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Email
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showie@mrc.gm
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Sponsor
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Medical Research Council (UK)
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Address
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20 Park Crescent
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City/town
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London
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Zip/Postcode
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W1B 1AL
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Country
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United Kingdom
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Tel
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+44 (0)20 7636 5422
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Fax
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+44 (0)20 7436 6179
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Email
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corporate@headoffice.mrc.ac.uk
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Sponsor website:
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http://www.mrc.ac.uk
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Date applied
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14/10/2005
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Last edited
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18/10/2010
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Date ISRCTN assigned
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21/10/2005
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