TY - JOUR
T1 - Efficacy of zinc supplementation for young infants with clinical severe infection in Tanzania
T2 - Study protocol for a randomised controlled trial
AU - Manji, Karim P.
AU - Somji, Sarah
AU - Bakari, Mohamed
AU - Fawzi, Wafaie W.
AU - Kibwana, Upendo
AU - Kisenge, Rodrick
AU - Kisumuni, Abuu S.
AU - Liu, Enju
AU - Mafie, Neema
AU - Maleko, Fredrick A.
AU - Salim, Nahya
AU - Duggan, Christopher P.
AU - Sudfeld, Christopher R.
N1 - Publisher Copyright:
© Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group.
PY - 2025/8/14
Y1 - 2025/8/14
N2 - 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.
AB - 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.
KW - Child Health
KW - Low and Middle Income Countries
KW - Mortality
KW - Neonatology
U2 - 10.1136/bmjpo-2025-003804
DO - 10.1136/bmjpo-2025-003804
M3 - Article
C2 - 40813142
AN - SCOPUS:105013398080
SN - 2399-9772
VL - 9
JO - Bmj Paediatrics Open
JF - Bmj Paediatrics Open
IS - 1
M1 - e003804
ER -
