article · BMJ Paediatrics Open
Severe bacterial infections such as sepsis, meningitis, and pneumonia are major causes of illness and death among young infants in low-income and middle-income nations. Zinc is a vital micronutrient supporting immune defence, suggesting its potential to enhance recovery and survival. A randomised, quadruple-blind clinical trial in Dar es Salaam, Tanzania, is evaluating the therapeutic effect of zinc supplementation in 3,250 infants aged 0 to 59 days presenting with clinical severe infection. Participants receive either 5 mg of elemental zinc as zinc citrate twice daily for 14 days or a matching placebo, with follow-up extending to 90 days. The trial focuses on two primary outcomes: all-cause mortality over 90 days and treatment failure, defined by hospital death, escalated respiratory support, vasoactive drug needs, or antibiotic changes. Secondary endpoints track wider health and nutritional metrics to assess overall clinical benefits.
Severe infections remain a major barrier to reducing infant mortality in sub-Saharan Africa. Determining whether an affordable, readily available micronutrient like zinc improves survival and clinical recovery could inform standard treatment protocols, supporting global targets to reduce preventable infant deaths in low-resource settings.
This research represents an applied clinical trial investigating an adjunct therapy for infant infections. If effective, the findings could inform treatment guidelines for healthcare providers, public health programmes, and pharmaceutical manufacturers producing paediatric zinc formulations. The intervention uses an existing therapeutic agent, but real-world clinical adoption depends on the trial's final outcome data.
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INTRODUCTION: Innovative interventions will be essential for countries in sub-Saharan Africa to achieve the 2030 Sustainable Development Goal for child mortality. Infections among young infants, including sepsis, meningitis and pneumonia, continue to cause a large burden of morbidity and mortality in low-income and middle-income countries. Zinc is an essential micronutrient with a well-established role in human health and immune system function, and supplementation may improve survival and treatment outcomes for infants with bacterial infections. METHODS AND ANALYSIS: We will conduct an individually randomised, quadruple-blind trial of zinc supplementation among 3250 infants 0-59 days old with clinical severe infection (CSI) in Dar es Salaam, Tanzania. Infants with CSI will be randomised to receive either (1) zinc citrate supplementation consisting of 5 mg elemental zinc taken two times per day for 14 days or (2) a matching placebo supplementation taken two times per day for 14 days. Infants will be followed for 90 days postrandomisation. The coprimary outcomes are (1) infant death (all-cause mortality to 90 days) and (2) treatment failure (composite outcome of death during initial hospitalisation, need for additional respiratory support, use of vasoactive medicines or change of antibiotics). Secondary outcomes include important infant health and nutritional outcomes. ETHICS AND DISSEMINATION: The trial protocol was approved by Harvard T. H. Chan School of Public Health Institutional Review Board, the Muhimbili University of Health and Allied Sciences Institutional Review Board, the National Health Research Ethics Sub-Committee and the Tanzania Medicine and Medical Device Authority. Findings will be disseminated locally, regionally and internationally at scientific conference presentations and as peer-reviewed publications. TRIAL REGISTRATION NUMBER: NCT06102044; ClinicalTrials.gov identifier.
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DOI: 10.1136/bmjpo-2025-003804
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