NCT00373100

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
328

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 2006

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

September 6, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 7, 2006

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

July 7, 2009

Status Verified

July 1, 2009

Enrollment Period

6 months

First QC Date

September 6, 2006

Last Update Submit

July 3, 2009

Conditions

Pneumonia

Keywords

Zincplacebosevere pneumoniachildren

Outcome Measures

Primary Outcomes (3)

  • Time taken for normalisation of respiratory rate

  • Time taken for normalisation of Temperature

  • Time taken for oxygen saturation to normalise

Secondary Outcomes (2)

  • Proportion of study children who will die during the follow up period

  • Proportion of children who develop drug adverse effects

Study Arms (2)

Zinc

EXPERIMENTAL

Zinc acetate

Drug: Zinc acetate

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Zinc acetateDRUG
Zinc
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

Age6 Months - 59 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 6- 59 months with cough, difficult breathing and chest indrawing
  • Written informed consent from the caretaker

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Paediatrics and Child Health, Makerere University

Kampala, Kampala, P O 7072, Uganda

Location

Related Publications (5)

  • 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.

    PMID: 15158629BACKGROUND

  • 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.

    PMID: 16685051BACKGROUND

  • 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.

    PMID: 12913795BACKGROUND

  • 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.

    PMID: 14985218BACKGROUND

  • 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.

    PMID: 22316073DERIVED

MeSH Terms

Conditions

Pneumonia

Interventions

Zinc Acetate

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Acetic AcidAcetatesAcids, AcyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Maheswari s Gurusamy, MBBS

    Department of Paediatrics and Child Health Makerere University, Kampala, Uganda

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 6, 2006

First Posted

September 7, 2006

Study Start

September 1, 2006

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

July 7, 2009

Record last verified: 2009-07

Locations

UG(1)