NCT00373100

The Efficacy of Zinc as Adjunct Therapy in the Treatment of Severe Pneumonia in Children Admitted to Mulago Hospital, Uganda.

Completed Phase 3 Last updated 3 July 2009

What this trial tests

Phase 3 trial testing Zinc acetate in Pneumonia in 328 participants. Completed in 1 March 2007.

Timeline

1 September 2006

Primary endpoint
1 March 2007

1 March 2007

Quick facts

Lead sponsor	Makerere University
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	328
Start date	1 September 2006
Primary completion	1 March 2007
Estimated completion	1 March 2007
Sites	1 location across Uganda

Drugs / interventions tested

• Zinc acetate (ZINC ACETATE) — full drug profile →
• Placebo

Conditions studied

• Pneumonia — all drugs for Pneumonia →

Sponsor

Makerere University

Who can join

Adults 6 Months to 59 Months, any sex, with Pneumonia. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Time taken for normalisation of respiratory rate
• Time taken for normalisation of Temperature
• Time taken for oxygen saturation to normalise

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Zinc adjunct therapy reduces case fatality in severe childhood pneumonia: a randomized double blind placebo-controlled trial.
   Srinivasan MG, Ndeezi G, Mboijana CK, Kiguli S, et al · · 2012 · cited 49× · PMID 22316073 · DOI 10.1186/1741-7015-10-14
2. Zinc supplementation as an adjunct to antibiotics in the treatment of pneumonia in children 2 to 59 months of age.
   Haider BA, Lassi ZS, Ahmed A, Bhutta ZA. · · 2011 · cited 19× · PMID 21975768 · DOI 10.1002/14651858.cd007368.pub2