Evidence map›Paper›PMID 40813142›Full record

ArticleBMJ paediatrics open2025

Efficacy of zinc supplementation for young infants with clinical severe infection in Tanzania: study protocol for a randomised controlled trial.

Karim P Manji, Sarah Somji, Mohamed Bakari, Wafaie W Fawzi, Upendo Kibwana, Rodrick Kisenge, Abuu S Kisumuni, Enju Liu, Neema Mafie, Fredrick A Maleko and 3 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ paediatrics open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06102044 (Trial of Zinc Supplements for Young Infants With Clinical Severe Infection in Tanzania), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06102044 phase3recruitingnot on this map

Trial of Zinc Supplements for Young Infants With Clinical Severe Infection in Tanzania

TypeinterventionalSponsorHarvard School of Public Health (HSPH)Ran2024 to 2027Enrolled3,250ConditionsNeonatal InfectionArmsZinc Supplements, Placebo Supplements
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Karim P ManjiDepartment of Pediatrics and Child Health, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.
Sarah SomjiCenter for Child, Adolescent, and Maternal Health Research, Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.ORCID http://orcid.org/0000-0001-6031-830X
Mohamed BakariDepartment of Pediatrics and Child Health, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.
Wafaie W FawziDepartment of Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.
Upendo KibwanaDepartment of Pediatrics and Child Health, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.
Rodrick KisengeDepartment of Pediatrics and Child Health, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.
Abuu S KisumuniDepartment of Pediatrics and Child Health, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.
Enju LiuInstitutional Centers for Clinical and Translational Research, Boston Children's Hospital, Boston, Massachusetts, USA.
Neema MafieDepartment of Pediatrics and Child Health, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.
Fredrick A MalekoDepartment of Pediatrics and Child Health, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.
Nahya SalimDepartment of Pediatrics and Child Health, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.
Christopher P DugganDepartment of Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.
Christopher R SudfeldDepartment of Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA csudfeld@hsph.harvard.edu.ORCID http://orcid.org/0000-0002-3203-3638

Funding

Trial of Zinc Supplements for Young Infants with Clinical Severe Infection in TanzaniaR01AI175348 · NIAID · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · PI CHRISTOPHER P DUGGAN, Christopher Sudfeld · 2023 to 2026
$2.4M
NIAID NIH HHS R01 AI175348
6 · The paper itself

Abstract

introductionInnovative 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.

Indexed as

Bacterial InfectionsDietary SupplementsZincDouble-Blind MethodFemaleHumansInfantInfant, NewbornMaleRandomized Controlled Trials as TopicTanzaniaTreatment OutcomeZincChild HealthLow and Middle Income CountriesMortalityNeonatology

Identifiers

PMID40813142
PMCPMC12352140

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.