The Efficacy of Zinc as Adjunct Therapy in the Treatment of Severe Pneumonia in Children - Full Text View

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:

MedlinePlus related topics: Pneumonia

Drug Information available for: Zinc acetate anhydrous Zinc acetate

U.S. FDA Resources

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

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:

Brooks WA, Yunus M, Santosham M, Wahed MA, Nahar K, Yeasmin S, Black RE. Zinc for severe pneumonia in very young children: double-blind placebo-controlled trial. Lancet. 2004 May 22;363(9422):1683-8.

Bose A, Coles CL, Gunavathi, John H, Moses P, Raghupathy P, Kirubakaran C, Black RE, Brooks WA, Santosham M. Efficacy of zinc in the treatment of severe pneumonia in hospitalized children <2 y old. Am J Clin Nutr. 2006 May;83(5):1089-96; quiz 1207.

Bitarakwate > E, Mworozi E, Kekitiinwa A. Serum zinc status of children with persistent diarrhoea admitted to the diarrhoea management unit of Mulago Hospital, Uganda. Afr Health Sci. 2003 Aug;3(2):54-60.

Mahalanabis D, Lahiri M, Paul D, Gupta S, Gupta A, Wahed MA, Khaled MA. Randomized, double-blind, placebo-controlled clinical trial of the efficacy of treatment with zinc or vitamin A in infants and young children with severe acute lower respiratory infection. Am J Clin Nutr. 2004 Mar;79(3):430-6.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Srinivasan MG, Ndeezi G, Mboijana CK, Kiguli S, Bimenya GS, Nankabirwa V, Tumwine JK. Zinc adjunct therapy reduces case fatality in severe childhood pneumonia: a randomized double blind placebo-controlled trial. BMC Med. 2012 Feb 8;10:14.

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

Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013