Respiratory Infections, Acute Clinical Trial
Official title:
The Effect of Zinc Supplementation on Duration of Hospitalization in Tanzanian Children Presenting With Acute Pneumonia
Undernutrition in children less than five years of age is common throughout sub-Saharan Africa. Nutritional deficiencies may lead to less ability to fight infectious diseases. The purpose of this study is to determine whether zinc supplements plus standard antibiotics reduce the length of hospitalization in children with pneumonia. Six hundred children aged 6-36 months diagnosed with pneumonia and admitted to Muhimbili National Hospital (MNH), Dar es Salaam, Tanzania, will participate in this study. Half of the children will receive daily supplements of zinc, and the other half will receive placebo tablets (dummy pills containing no medication). Each child will be followed for 6 weeks after hospital discharge to check for recovery from the illness. All children in both groups will receive antibiotics and supportive care to manage pneumonia, according to the standards of care at MNH and Amana Municipal Hospital in accordance with the Recommendations of the Ministry of Health, Tanzania.
Undernutrition in children less than five years of age is prevalent throughout sub-Saharan Africa and is often associated with multiple micronutrient deficiencies, such as vitamin A and zinc. These deficiencies are probably a reflection of the poverty and poor living conditions that contribute to the lack of proper nutrition. The potential adverse effect of even subclinical deficiency in various micronutrients (including zinc) on optimal physiological function may lead to an exacerbation of infectious diseases in children living in these parts of the world. The primary objective of this randomized, double-blind, placebo-controlled study is to determine whether oral zinc supplementation plus standard antibiotics significantly alters the duration of required hospitalization in children with radiologically confirmed acute pneumonia. Six hundred children aged six months to 36 months diagnosed with radiologically confirmed acute pneumonia and admitted in the general pediatric wards of Muhimbili National Hospital (MNH), Dar es Salaam, Tanzania, will be recruited. Upon enrollment, half of the subjects will receive daily oral supplements of 25 mg of elemental zinc and the control group will receive placebo tablets. Children randomized to receive zinc supplements will be given a daily dose of 25 mL of reconstituted solution from effervescent tablets equivalent to 25 mg of elemental zinc in two divided doses (12.5 mg twice daily) by a study coordinator during the hospital phase of treatment for pneumonia. Children randomized to the control group will receive placebo effervescent tablets identical in taste and appearance to those tablets containing zinc. Compliance to the regimen will be directly observed by the study coordinator, and clinical response will be closely monitored throughout hospital stay. Each child will be followed for six weeks after hospital discharge to assess for recovery from the illness. All children in both groups will receive antibiotics and supportive care to manage pneumonia, as deemed appropriate according to the standards of care as practiced at MNH and Amana Municipal Hospital in accordance with the Recommendations of the Ministry of Health, Tanzania. ;
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