The Efficacy of Zinc as Adjunct Therapy in the Treatment of Severe Pneumonia in Children

Phase 3

Completed

• Conditions: Pneumonia
• Interventions: Drug: Zinc acetate; Drug: Placebo

• Registration Number: NCT00373100
• Lead Sponsor: Makerere University

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2006-09-06
• Study First Submitted QC: 2006-09-06
• Study First Posted: 2006-09-07
• Primary Completion: 2007-03
• Study Completion: 2007-03
• Status Verified: 2009-07
• Last Update Submitted: 2009-07-03
• Last Update Posted: 2009-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 328

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Zinc	Zinc acetate	Zinc acetate
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Time taken for normalisation of respiratory rate
Time taken for normalisation of Temperature
Time taken for oxygen saturation to normalise

Secondary Outcome Measures

Name	Time	Method
Proportion of study children who will die during the follow up period
Proportion of children who develop drug adverse effects

Trial Locations

Locations (1)

Department of Paediatrics and Child Health, Makerere University; 🇺🇬 Kampala, Uganda