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Recruiting NCT06102044

Zinc Supplementation for Young Infants With Clinical Severe Infection in Tanzania

Phase III Interventional Neonatal Infection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Zinc Supplements, Placebo Supplements.
Who it may be relevant to
Registry conditions: Neonatal Infection. Basic parameters: 0 Days — 59 Days · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Tanzania
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

Bacterial infections among young infants, including sepsis, meningitis, and pneumonia, continue to cause a substantial number of deaths globally. Zinc supplementation in combination with standard antibiotic therapy may represent a new intervention to reduce mortality and improve treatment outcomes for young infants with clinical severe infection. The Investigators will conduct a randomized, double-blind, placebo-controlled trial of zinc supplementation among young infants 0-59 days with severe clinical infection. The trial will enroll 3,250 Tanzanian infants hospitalized with clinical severe infection as defined by WHO Integrated Management of Childhood Illness (IMCI) guidelines. Enrolled infants will receive standard clinical management including antibiotics and will be randomized to receive either a 14-day course of twice-daily 5 mg elemental zinc (10 mg per day) or a matching placebo regimen.

Interventions

  • Dietary supplement Zinc Supplements
    Dispersible zinc citrate tablets
  • Dietary supplement Placebo Supplements
    Dispersible placebo tablets

Primary outcome measures

  • Death [Time frame: 90 Days]
  • Treatment Failure [Time frame: From date of randomization until the date of first documented treatment failure or date of death from any cause during the initial hospitalization, whichever comes first, assessed up to 90 days]
Secondary outcome measures (12)
  • Death during initial hospitalization [Time frame: Randomization to the date of initial hospitalization discharge, assessed up to 90 days]
  • Duration of initial hospital stay [Time frame: Randomization to Day 90]
  • Duration of signs of clinical severe infection [Time frame: Randomization to Day 90]
  • Diarrhea during initial hospital admission [Time frame: Randomization to the date of initial hospitalization discharge, assessed up to 90 days]
  • Rate of vomiting related to regimen dosing [Time frame: Randomization to Day 15]
  • Re-hospitalization [Time frame: Date of initial hospitalization discharge to Day 90]
  • Presence of any sign of possible severe bacterial infection at Day 15 [Time frame: Day 15]
  • Presence of any sign of possible severe bacterial infection at Day 90 [Time frame: Day 90]
  • Proportion of Children with Diarrhea at Day 15 or Day 90 [Time frame: Day 15 and Day 90]
  • Infant length-for-age z-score at Day 15 [Time frame: Day 15]
  • Infant length-for-age z-score at Day 90 [Time frame: Day 90]
  • Infant weight-for-age z-score at Day 15 [Time frame: Day 15]

Eligibility criteria

Inclusion criteria

  • Young infants aged 0-59 days
  • Diagnosis of clinical severe infection (CSI)
  • Ability to feed enterally
  • Intend to stay in the study area for 90 days
  • Provided informed consent

Exclusion criteria

  • Prior use of zinc supplements during the current illness
  • Receipt of antibiotics for >24 hours before enrollment
  • Diarrhea at enrollment
  • Signs suggestive of serious illness/condition that is not clinical severe infection
  • Previously enrolled in the trial
  • Enrolled in other research study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Tanzania · 1 center
  • Muhimbili University of Health and Allied Sciences — Dar es Salaam

Publications

  • Manji KP, Somji S, Bakari M, Fawzi WW, Kibwana U, Kisenge R, Kisumuni AS, Liu E, Mafie N, Maleko FA, Salim N, Duggan CP, Sudfeld CR. Efficacy of zinc supplementation for young infants with clinical severe infection in Tanzania: study protocol for a randomised controlled trial. BMJ Paediatr Open. 2025 Aug 14;9(1):e003804. doi: 10.1136/bmjpo-2025-003804. PMID 40813142

Identifiers

NCT: NCT06102044 · IRB23-0138

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗