Randomized trials carried out elsewhere in the developing countries have shown that dietary zinc supplementation in apparently healthy children reduces pneumonia incidence by 41%, however, all the studies that were analyzed had looked at the efficacy of zinc supplementation on the incidence of pneumonia during a prospective follow-up period and none had looked at the effect of zinc supplements on an episode of respiratory disease during the course of treatment. We propose to undertake a randomized, double blind, placebo-controlled trial to examine whether daily oral supplement of 10 mg of elemental zinc will reduce severity of respiratory disease among children admitted at Muhimbili National Hospital, Dares Salaam, Tanzania with radiographically confirmed pneumonia. Six hundred children aged between 6 months and 5 years who will be admitted because of radiologically confirmed pneumonia and whose parents/caretakers will give consent will be recruited during a 3-year study period and will be randomly assigned to receive either daily zinc supplements or placebo and the outcome between the two groups will be closely monitored and documented to determine any beneficial effects of zinc supplements on the course of hospital treatment of pneumonia with duration of hospital stay, fever, rapid respiratory rate and hypoxia as endpoints of interest After discharge from hospital each patient will be followed for duration of 6 months, once every month at study clinic at Muhimbili National Hospital to determine the effect of zinc supplements on growth patterns using increment in weight and height as endpoints. Baseline laboratory investigations to determine serum zinc levels, hematological profile and on consent HIV status will be done and a repeat of serum zinc levels will be done at the end of 6 month follow-up period for each child. At the end of the study appropriate statistical tests will be done to analyze the effects between the two study groups and dissemination of the information will be done.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Project (R01)
Project #
5R01AI056235-02
Application #
6799267
Study Section
Special Emphasis Panel (ZRG1-ICP (02))
Program Officer
Taylor, Christopher E,
Project Start
2003-09-15
Project End
2006-08-31
Budget Start
2004-09-01
Budget End
2005-08-31
Support Year
2
Fiscal Year
2004
Total Cost
$101,082
Indirect Cost
Name
Muhimbili University/ Allied Health Sciences
Department
Type
DUNS #
565438611
City
Dar Es Salaam
State
Country
Tanzania U Rep
Zip Code
65001