Efficacy of zinc as an adjunct therapy in the management of severe pneumonia among Gambian children

ISRCTN ISRCTN33548493
DOI https://doi.org/10.1186/ISRCTN33548493
Protocol serial number SCC967
Sponsor Medical Research Council (UK)
Funder Medical Research Council (UK)
Submission date
14/10/2005
Registration date
21/10/2005
Last edited
07/01/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Stephen Howie
Scientific

MRC Laboratories
P.O. Box 273
Banjul
000 000
Gambia

+220 4494438
showie@mrc.gm

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Scientific titleEfficacy of zinc as an adjunct therapy in the management of severe pneumonia among Gambian children
Study objectivesZinc supplementation given to Gambian children as an adjunct therapy in severe or very severe pneumonia will be associated with more rapid recovery.
Ethics approval(s)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)
Health condition(s) or problem(s) studiedSevere and very severe pneumonia defined clinically
InterventionInterventions 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 typeSupplement
Primary outcome measure(s)

Treatment failure at 5 days

Key secondary outcome measure(s)

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

Completion date31/03/2011

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit2 Months
Upper age limit59 Months
SexNot Specified
Target sample size at registration600
Total final enrolment604
Key inclusion criteriaPrior 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.
Key exclusion criteriaChildren with severe malnutrition or signs of systemic infection other than pneumonia
Date of first enrolment24/10/2005
Date of final enrolment31/03/2011

Locations

Countries of recruitment

  • Gambia

Study participating centre

MRC Laboratories
Banjul
000 000
Gambia

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/06/2018 07/01/2021 Yes No

Editorial Notes

07/01/2021: Publication reference and total final enrolment added.

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