Therapeutic Zinc in Childhood Pneumonia
Condition: Pneumonia
MeSH terms: Pneumonia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The aim of this study is to assess whether zinc given as adjuvant therapy to standard
      antibiotic treatment in children hospitalized for severe pneumonia reduces the duration of
      the severe illness and risk of treatment failure. A randomized double blind placebo
      controlled clinical trial will be conducted at the Kanti Hospital.
    

Detailed description: 
      Nepal has an under-five mortality rate of 91/1000 live births. Pneumonia, one of the major
      killers accounts for the death of 25,000 - 35,000 Nepalese children every year. It is
      estimated that, on an average, of 1000 children <5 years of age that visit health facilities,
      90 have pneumonia of which 4.2 have severe pneumonia. At the Kanti Children's Hospital,
      respiratory diseases are the most frequent reason for admission and the second most frequent
      cause of child death Zinc, an important micronutrient, is crucial for the normal function of
      the immune system as well as the integrity of the respiratory epithelium. Zinc deficiency is
      associated with an increased incidence and severity of diarrhea and respiratory tract
      infections. The preventive effect of zinc on diarrheal and respiratory illness has been well
      documented.

      Early in an infection zinc is shifted into the liver from the plasma, bone, skin and
      intestines. For a child with initial low zinc levels, even relatively trivial infections may
      cause entry into the vicious cycle of reduced plasma zinc and increased infection severity.
      Administration of zinc during the acute illness may help in reducing the severity of illness.

      The therapeutic effect of zinc in acute diarrhea has been well documented. In a study
      conducted at Bhaktapur, Nepal, in children 6 to 36 months of age, supplementation with zinc
      was found to be highly effective in the treatment of acute diarrhea.

      The Kanti Children's Hospital in Kathmandu serves as a general and referral hospital for
      children from all parts of the country. Approximately 25% of all admissions to this hospital
      are due to pneumonia. Being the only well recognized children's hospital, there is always a
      constraint for available beds for children presenting with pneumonia. Zinc as an adjuvant to
      standard treatment of pneumonia with antimicrobials was found to hasten recovery from severe
      pneumonia in children less than 2 years of age in Bangladesh . If we were to conduct a
      similar study and prove that zinc does in fact help to shorten the duration of illness in
      children with severe pneumonia, it would go a long way in contributing to improve case
      management.
    

Intervention name(s): Zinc (zinc sulphate); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Dissolvable zinc tablet 10 mg elemental zinc per day for infants 20 mg elemental zinc per day for children 12 to 35 months; Placebo
Other intervention name(s): Produced by Nutriset; Malaunay, France; Produced by Nutriset; Malaunay, France
Intervention MeSH terms: Zinc Sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Child, severe pneumonia, Zinc, Nepal, therapeutic