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

Sponsored by:	Makerere University
Information provided by:	Makerere University
ClinicalTrials.gov Identifier:	NCT00373100

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 sulphate	Phase III

MedlinePlus related topics: Pneumonia

Drug Information available for: Zinc sulfate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	The Efficacy of Zinc as Adjunct Therapy in the Treatment of Severe Pneumonia in Children Admitted to Mulago Hospital, Uganda.

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
Estimated Study Completion Date:	June 2007

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

Contacts

Contact: James K Tumwine, PhD	+256 772 494120	jtumwine @imul.com
Contact: Grace Ndeezi, MMED	+256 772 453191	gracendeezi@ yahoo.com

Locations

Uganda
Department of Paediatrics and Child Health, Makerere University	Recruiting
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.

Study ID Numbers:	HD1120041349X
Study First Received:	September 6, 2006
Last Updated:	September 13, 2006
ClinicalTrials.gov Identifier:	NCT00373100
Health Authority:	Uganda: National Council for Science and Technology

Keywords provided by Makerere University:

Zinc
placebo
severe pneumonia
children

Study placed in the following topic categories:

Respiratory Tract Infections
Respiratory Tract Diseases
Zinc Sulfate

Lung Diseases
Zinc
Pneumonia

Additional relevant MeSH terms:

Therapeutic Uses
Growth Substances
Physiological Effects of Drugs
Astringents

Trace Elements
Micronutrients
Dermatologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009