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

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ClinicalTrials.gov Identifier: NCT00373100
Recruitment Status : Completed
First Posted : September 7, 2006
Last Update Posted : July 7, 2009
Sponsor:
Information provided by:
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.


Condition or disease Intervention/treatment Phase
Pneumonia Drug: Zinc acetate Drug: Placebo Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 328 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: The Efficacy of Zinc as Adjunct Therapy in the Treatment of Severe Pneumonia in Children Admitted to Mulago Hospital, Uganda.
Study Start Date : September 2006
Actual Primary Completion Date : March 2007
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Zinc
Zinc acetate
Drug: Zinc acetate
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo




Primary Outcome Measures :
  1. Time taken for normalisation of respiratory rate
  2. Time taken for normalisation of Temperature
  3. Time taken for oxygen saturation to normalise

Secondary Outcome Measures :
  1. Proportion of study children who will die during the follow up period
  2. Proportion of children who develop drug adverse effects


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00373100


Locations
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Uganda
Department of Paediatrics and Child Health, Makerere University
Kampala, Uganda, P O 7072
Sponsors and Collaborators
Makerere University
Investigators
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Principal Investigator: Maheswari s Gurusamy, MBBS Department of Paediatrics and Child Health Makerere University, Kampala, Uganda

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: James K Tumwine, Department of Paediatrics and Child Health Makerere University
ClinicalTrials.gov Identifier: NCT00373100     History of Changes
Other Study ID Numbers: HD1120041349X
First Posted: September 7, 2006    Key Record Dates
Last Update Posted: July 7, 2009
Last Verified: July 2009
Keywords provided by Makerere University:
Zinc
placebo
severe pneumonia
children
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Zinc
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs