A Phase 3 interventional study of Zinc acetate and Placebo in Pneumonia, sponsored by Makerere University. Completed at 1 site in Uganda. Open to participants aged 6 Months to 59 Months. Per ClinicalTrials.gov, last updated 2009-07-07.
Sponsored by Makerere University · Phase 3, Interventional, and Treatment
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.
2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.
This study's planned enrollment of 328 is above the median of 106 across 1,247 interventional studies indexed under Pneumonia.
Browse Pneumonia studies →Makerere University is the lead sponsor of 143 studies on the registry; 16 are open to participants now.
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Zinc acetate
Drug: Zinc acetate
Placebo
Drug: Placebo
Placebo
Time taken for normalisation of respiratory rate
Time taken for normalisation of Temperature
Time taken for oxygen saturation to normalise
Proportion of study children who will die during the follow up period
Proportion of children who develop drug adverse effects
This study is completed, as verified in Jul 2009. You cannot join it, but the record below documents what was studied.
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Makerere University