The Efficacy of Zinc as Adjunct Therapy in the Treatment of Severe Pneumonia in Children
NCT00373100 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 328
Last updated 2009-07-07
Summary
Pneumonia is a leading cause of morbidity and mortality in children in developing countries. Zinc deficiency leads to impairment in tissue repair and immunodeficiency in children.At least two randomised controlled trials have shown that zinc supplementation improves the outcome of severe pneumonia in children (reducing duration of hospital stay and complications related to pneumonia).
However, there are conflicting results from other randomised controlled trials about its efficacy in children with pneumonia.The purpose of the current study is to determine the efficacy of zinc as adjunct therapy for in severe pneumonia in children aged 6-59 months. We hypothesize that the proportion of children who recover from severe pneumonia following zinc adjunct therapy \[(10 mg once daily for seven days) for children aged \<12 months and 20 mg daily for children aged ≥12 months\]will be higher than the proportion of children who recover from placebo therapy.
Conditions
Interventions
- DRUG
-
Zinc acetate
- DRUG
-
Placebo
Sponsors & Collaborators
-
Makerere University
lead OTHER
Principal Investigators
-
Maheswari s Gurusamy, MBBS · Department of Paediatrics and Child Health Makerere University, Kampala, Uganda
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 6 Months
- Max Age
- 59 Months
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-09-30
- Primary Completion
- 2007-03-31
- Completion
- 2007-03-31
Countries
- Uganda
Study Locations
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