Few controlled studies have evaluated the impact of therapeutic use of elemental zinc in children with pneumonia. Results from two previous studies, one in Bangladesh (Brooks et al., 2004) and the other in Kolkata, India (Mahalanabis et al., 2004), showed zinc supplemented children have a shorter duration of recovery from severe pneumonia than those on placebo. However, a trial conducted in South India found zinc to have no effect on recovery status (Bose et al., 2006) Differences in study populations and methods between previous trials and the South Indian study may have affected the study results. There exists conflicting information regarding the efficacy of zinc as an adjunct to treatment for pneumonia in children. This study will provide necessary information regarding the impact, as measured by the time taken to recovery, of zinc supplementation as an adjunct to standard antimicrobial therapy for severe and very severe pneumonia in children 2-24 months of age. This double-blind, randomized, placebo-controlled trial will take place across three hospitals in New Delhi, India and will test the efficacy of daily oral administration of 20mg of elemental zinc in hospitalized children with severe pneumonia. The results will be important for global policymaking to reduce the morbidity and mortality burden of respiratory diseases in young children around the world. Principal Investigators: Co-Investigators: References: 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. 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. 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. |