Pneumonia Clinical Trial
Official title:
The Efficacy of Zinc as Adjunct Therapy in the Treatment of Severe Pneumonia in Children Admitted to Mulago Hospital, Uganda.
Verified date | July 2009 |
Source | Makerere University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Uganda: National Council for Science and Technology |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 328 |
Est. completion date | March 2007 |
Est. primary completion date | March 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 6 Months to 59 Months |
Eligibility |
Inclusion Criteria: - Children aged 6- 59 months with cough, difficult breathing and chest indrawing - Written informed consent from the caretaker Exclusion Criteria: - Children with known heart disease - Children on medication with Zinc supplements - Children with obstructive air way disease - Children with active measles - Known intolerance or allergy to zinc or zinc-containing products |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Uganda | Department of Paediatrics and Child Health, Makerere University | Kampala |
Lead Sponsor | Collaborator |
---|---|
Makerere University |
Uganda,
Bitarakwate E, Mworozi E, Kekitiinwa A. Serum zinc status of children with persistent diarrhoea admitted to the diarrhoea management unit of Mulago Hospital, Uganda. Afr Health Sci. 2003 Aug;3(2):54-60. — View Citation
Bose A, Coles CL, Gunavathi, John H, Moses P, Raghupathy P, Kirubakaran C, Black RE, Brooks WA, Santosham M. Efficacy of zinc in the treatment of severe pneumonia in hospitalized children <2 y old. Am J Clin Nutr. 2006 May;83(5):1089-96; quiz 1207. — View Citation
Brooks WA, Yunus M, Santosham M, Wahed MA, Nahar K, Yeasmin S, Black RE. Zinc for severe pneumonia in very young children: double-blind placebo-controlled trial. Lancet. 2004 May 22;363(9422):1683-8. — View Citation
Mahalanabis D, Lahiri M, Paul D, Gupta S, Gupta A, Wahed MA, Khaled MA. Randomized, double-blind, placebo-controlled clinical trial of the efficacy of treatment with zinc or vitamin A in infants and young children with severe acute lower respiratory infection. Am J Clin Nutr. 2004 Mar;79(3):430-6. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time taken for normalisation of respiratory rate | |||
Primary | Time taken for normalisation of Temperature | |||
Primary | Time taken for oxygen saturation to normalise | |||
Secondary | Proportion of study children who will die during the follow up period | |||
Secondary | Proportion of children who develop drug adverse effects |
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