{
  "abstract": "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",
  "authors": [
    {
      "affiliations": [
        "Department of Pediatrics and Child Health, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania"
      ],
      "name": "Karim P Manji"
    },
    {
      "affiliations": [
        "Center for Child, Adolescent, and Maternal Health Research, Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland",
        "Department of Epidemiology, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania"
      ],
      "name": "Sarah Somji"
    },
    {
      "affiliations": [
        "Department of Pediatrics and Child Health, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania"
      ],
      "name": "Mohamed Bakari"
    },
    {
      "affiliations": [
        "Department of Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA",
        "Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA",
        "Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA"
      ],
      "name": "Wafaie W Fawzi"
    },
    {
      "affiliations": [
        "Department of Pediatrics and Child Health, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania"
      ],
      "name": "Upendo Kibwana"
    },
    {
      "affiliations": [
        "Department of Pediatrics and Child Health, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania"
      ],
      "name": "Rodrick Kisenge"
    },
    {
      "affiliations": [
        "Department of Pediatrics and Child Health, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania"
      ],
      "name": "Abuu S Kisumuni"
    },
    {
      "affiliations": [
        "Institutional Centers for Clinical and Translational Research, Boston Children's Hospital, Boston, Massachusetts, USA",
        "Center for Nutrition, Division of Gastroenterology, Hepatology, and Nutrition, Boston Children's Hospital, Boston, Massachusetts, USA"
      ],
      "name": "Enju Liu"
    },
    {
      "affiliations": [
        "Department of Pediatrics and Child Health, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania"
      ],
      "name": "Neema Mafie"
    },
    {
      "affiliations": [
        "Department of Pediatrics and Child Health, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania"
      ],
      "name": "Fredrick A Maleko"
    },
    {
      "affiliations": [
        "Department of Pediatrics and Child Health, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania"
      ],
      "name": "Nahya Salim"
    },
    {
      "affiliations": [
        "Department of Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA",
        "Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA",
        "Center for Nutrition, Division of Gastroenterology, Hepatology, and Nutrition, Boston Children's Hospital, Boston, Massachusetts, USA"
      ],
      "name": "Christopher P Duggan"
    },
    {
      "affiliations": [
        "Department of Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA",
        "Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA"
      ],
      "name": "Christopher R Sudfeld"
    }
  ],
  "title": "Efficacy of zinc supplementation for young infants with clinical severe infection in Tanzania: study protocol for a randomised controlled trial",
  "uid": "e8653df2-d010-5598-ace4-0c12a2739cd9"
}