Clinical trial NCT00373100: The Efficacy of Zinc as Adjunct Therapy in the Treatment of Severe Pneumonia in Children
Official title: The Efficacy of Zinc as Adjunct Therapy in the Treatment of Severe Pneumonia in Children Admitted to Mulago Hospital, Uganda.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pneumonia
Keywords: Zinc
placebo
severe pneumonia
children
Lead sponsor: Makerere University
Sponsor class: OTHER
First posted: 2006-09-07
Enrollment: 328
Sex: ALL
Minimum age (years): 6
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Time taken for normalisation of respiratory rate
measure: Time taken for normalisation of Temperature
measure: Time taken for oxygen saturation to normalise
Secondary outcomes:
measure: Proportion of study children who will die during the follow up period
measure: Proportion of children who develop drug adverse effects
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Department of Paediatrics and Child Health, Makerere University
Study officials:
affiliation: Department of Paediatrics and Child Health Makerere University, Kampala, Uganda
name: Maheswari s Gurusamy, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1016/S0140-6736(04)16252-1.
citation: 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. doi: 10.1093/ajcn/83.5.1089.
citation: 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.
citation: 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. doi: 10.1093/ajcn/79.3.430.
citation: 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. doi: 10.1186/1741-7015-10-14.