Zinc Supplementation for Young Infants With Clinical Severe Infection in Tanzania

NCT06102044 | Recruiting Phase 3 DMC

• 1 other identifier: IRB23-0138
• Study Type: interventional
• Target: 3,250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neonatal Infection

Outcome Measures

Primary Outcomes (2)

• Death

  All-cause infant death

  90 Days

• Treatment Failure

  A composite endpoint of death during initial period of hospitalization, the need for additional respiratory support (either mechanical ventilation, or positive end expiratory pressure support) or the use of vasoactive medicines to support blood pressure or need to change antibiotics during the initial hospitalization

  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 Outcomes (16)

• Death during initial hospitalization

  Randomization to the date of initial hospitalization discharge, assessed up to 90 days

• Duration of initial hospital stay

  Randomization to Day 90

• Duration of signs of clinical severe infection

  Randomization to Day 90

• Diarrhea during initial hospital admission

  Randomization to the date of initial hospitalization discharge, assessed up to 90 days

• Rate of vomiting related to regimen dosing

  Randomization to Day 15

Study Arms (2)

Zinc Supplementation

EXPERIMENTAL

14-day regimen of twice-daily 5 mg elemental zinc supplements to be taken orally or by enteral feeding tube

Dietary Supplement: Zinc Supplements

Placebo

PLACEBO COMPARATOR

14-day regimen of twice-daily oral placebo supplements to be taken orally or by enteral feeding tube

Dietary Supplement: Placebo Supplements

Interventions

Zinc Supplements DIETARY_SUPPLEMENT

Dispersible zinc citrate tablets

Zinc Supplementation

Placebo Supplements DIETARY_SUPPLEMENT

Dispersible placebo tablets

Placebo

Eligibility Criteria

• Age: 0 Days - 59 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Harvard School of Public Health (HSPH): lead
• Muhimbili University of Health and Allied Sciences: collaborator

Study Sites (1)

Muhimbili University of Health and Allied Sciences

Dar es Salaam, Tanzania

RECRUITING

Related Publications (1)

• 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 BACKGROUND

Study Officials

• Christopher R Sudfeld, ScD

  Harvard School of Public Health (HSPH)

  PRINCIPAL INVESTIGATOR

• Christopher P Duggan, MD

  Harvard School of Public Health (HSPH) and Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

• Karim P Manji, MD

  Muhimbili University of Health and Allied Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher R Sudfeld, ScD

CONTACT

(617) 432-5051; csudfeld@hsph.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Global Health and Nutrition

Study Record Dates

• First Submitted: October 20, 2023
• First Posted: October 26, 2023
• Study Start: December 27, 2024
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): October 30, 2027
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

TA (1)