randomized controlled trial of the effect of zinc as adjuvant therapy in children 2-35 mo of age with severe or nonsevere pneumonia in Bhaktapur, Nepal

• Published in: The American journal of clinical nutrition 2010-06, Vol.91 (6), p.1667-1674
• Main Authors: Valentiner-Branth, Palle, Shrestha, Prakash S, Chandyo, Ram K, Mathisen, Maria, Basnet, Sudha, Bhandari, Nita, Adhikari, Ramesh K, Sommerfelt, Halvor, Strand, Tor A
• Format: Article
• Language: English
• Subjects: Anti-Bacterial Agents - administration & dosage; Antibiotics; Biological and medical sciences; C-Reactive Protein - metabolism; child nutrition; Child, Preschool; children; Children & youth; dietary mineral supplements; dietary minerals; Dietary supplements; disease severity; Double-Blind Method; drug adjuvants; Drug therapy; Feeding. Feeding behavior; Female; Fundamental and applied biological sciences. Psychology; Hemoglobins - metabolism; Humans; Infant; Male; Medical research; Nepal; Oximetry; Pneumonia; Pneumonia - blood; Pneumonia - drug therapy; randomized clinical trials; Respiration; Treatment Failure; Trimethoprim, Sulfamethoxazole Drug Combination - administration & dosage; Vertebrates: anatomy and physiology, studies on body, several organs or systems; Zinc; Zinc - administration & dosage; Zinc - blood
• ISSN: 0002-9165; 1938-3207
• DOI: 10.3945/ajcn.2009.28907

BACKGROUND: Pneumonia is a leading cause of illness and death in young children. Interventions to improve case management of pneumonia are needed. OBJECTIVE: Our objective was to measure the effect of zinc supplementation in children with pneumonia in a population in which zinc deficiency is common. DESIGN: In a double-blind, placebo-controlled clinical trial, children aged 2-35 mo with severe (n = 149) or nonsevere (n = 2479) pneumonia defined according to criteria established by the World Health Organization were randomly assigned to receive zinc (10 mg for children aged 2-11 mo, 20 mg for children aged ≥12 mo) or placebo daily for 14 d as an adjuvant to antibiotics. The primary outcomes were treatment failure, defined as a need for change in antibiotics or hospitalization, and time to recovery from pneumonia. RESULTS: One of 5 children did not respond adequately to antibiotic treatment; the odds ratios between zinc and placebo groups for treatment failure were 0.95 (95% CI: 0.78, 1.2) for nonsevere pneumonia and 0.97 (95% CI: 0.42, 2.2) for severe pneumonia. There was no difference in time to recovery between zinc and placebo groups for nonsevere (median: 2 d; hazard ratio: 1.0; 95% CI: 0.96, 1.1) or severe (median: 4 d; hazard ratio: 1.1; 95% CI: 0.79, 1.5) pneumonia. Regurgitation or vomiting [less-than or equal to]15 min after supplementation was observed more frequently among children in the zinc group than among those in the placebo group during the supplementation period (37% compared with 13%; odds ratio: 0.25; 95% CI: 0.20, 0.30). CONCLUSION: Adjuvant treatment with zinc neither reduced the risk of treatment failure nor accelerated recovery in episodes of nonsevere or severe pneumonia. This trial was registered at clinicaltrials.gov as NCT00148733.