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

This study has been completed.
Sponsor:
Information provided by:
Makerere University
ClinicalTrials.gov Identifier:
NCT00373100
First received: September 6, 2006
Last updated: July 3, 2009
Last verified: July 2009

September 6, 2006
July 3, 2009
September 2006
March 2007   (final data collection date for primary outcome measure)
  • Time taken for normalisation of respiratory rate
  • Time taken for normalisation of Temperature
  • Time taken for oxygen saturation to normalise
Same as current
Complete list of historical versions of study NCT00373100 on ClinicalTrials.gov Archive Site
  • Proportion of study children who will die during the follow up period
  • Proportion of children who develop drug adverse effects
Same as current
Not Provided
Not Provided
 
The Efficacy of Zinc as Adjunct Therapy in the Treatment of Severe Pneumonia in Children
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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Pneumonia
  • Drug: Zinc acetate
  • Drug: Placebo
    Placebo
    Other Name: Placebo
  • Experimental: Zinc
    Zinc acetate
    Intervention: Drug: Zinc acetate
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
328
March 2007
March 2007   (final data collection date for primary outcome measure)

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
Both
6 Months to 59 Months
No
Contact information is only displayed when the study is recruiting subjects
Uganda
 
NCT00373100
HD1120041349X
Yes
James K Tumwine, Department of Paediatrics and Child Health Makerere University
Makerere University
Not Provided
Principal Investigator: Maheswari s Gurusamy, MBBS Department of Paediatrics and Child Health Makerere University, Kampala, Uganda
Makerere University
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP