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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
  Purpose

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 Intervention Phase
Pneumonia
Drug: Zinc acetate
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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.

Resource links provided by NLM:


Further study details as provided by Makerere University:

Primary Outcome Measures:
  • Time taken for normalisation of respiratory rate
  • Time taken for normalisation of Temperature
  • Time taken for oxygen saturation to normalise

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

Estimated Enrollment: 328
Study Start Date: September 2006
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Zinc
Zinc acetate
Drug: Zinc acetate
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo
Other Name: Placebo

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.

  Eligibility

Ages Eligible for Study:   6 Months to 59 Months
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00373100

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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Study First Received: September 6, 2006
Last Updated: July 3, 2009
Health Authority: Uganda: National Council for Science and Technology

Keywords provided by Makerere University:
Zinc
placebo
severe pneumonia
children

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Zinc
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Trace Elements

ClinicalTrials.gov processed this record on November 20, 2014