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 |
| Secondary identifying numbers | SCC967 |
- 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
Scientific
MRC Laboratories
P.O. Box 273
Banjul
000 000
Gambia
| Phone | +220 4494438 |
|---|---|
| showie@mrc.gm |
Study information
| 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 | Efficacy of zinc as an adjunct therapy in the management of severe pneumonia among Gambian children |
| Study objectives | 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(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) studied | 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 |
| Primary outcome measure | 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 study start date | 24/10/2005 |
| Completion date | 31/03/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 2 Months |
| Upper age limit | 59 Months |
| Sex | Not Specified |
| Target number of participants | 600 |
| Total final enrolment | 604 |
| Key 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. |
| Key exclusion criteria | Children with severe malnutrition or signs of systemic infection other than pneumonia |
| Date of first enrolment | 24/10/2005 |
| Date of final enrolment | 31/03/2011 |
Locations
Countries of recruitment
- Gambia
Study participating centre
MRC Laboratories
Banjul
000 000
Gambia
000 000
Gambia
Sponsor information
Medical Research Council (UK)
Research council
Research council
20 Park Crescent
London
W1B 1AL
United Kingdom
| Phone | +44 (0)20 7636 5422 |
|---|---|
| corporate@headoffice.mrc.ac.uk | |
| Website | http://www.mrc.ac.uk |
"ROR" |
https://ror.org/03x94j517 |
Funders
Funder type
Research council
Medical Research Council (UK)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| 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 |
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.
