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.
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.
Zinc deficiency is a global nutritional problem affecting people with a low socioeconomic
status in developing and developed countries. There is a high prevalence of zinc deficiency
in Uganda as documented by Bitarakwate et al.Two clinical studies have shown that zinc
supplementation improves the outcome of severe pneumonia in children by reducing duration of
hospital stay and complications related to pneumonia. However, there are conflicting results
from some previous studies about its usefulness in patients with pneumonia.
The objective of this study is to determine the effect of zinc supplement as adjunct therapy
in the treatment of severe pneumonia in children less than five years admitted to Mulago
hospital, Kampala, Uganda.
This will be a randomized, double-blinded, placebo-controlled trial of zinc adjucnt therapy.
Three hundred and twenty eight children with severe pneumonia will be randomised to receive
either zinc (a daily dose of 20 mg for children more than one of age and 10mg for those less
than one year or placebo once daily for seven days.
The primary outcome will be Time taken to :normalisation of respiratory rate, temperature
and oxygen saturation.
Secondary outcome:Proportion of study children who will die during the follow up
period,Proportion of children who develop drug adverse effects data will be analysed using
Kaplan Meir survival curves.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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